LOW-BACK PAIN: FREQUENCY, MANAGEMENT AND PREVENTION FROM AN HTA PERSPECTIVE

DIHTA - Danish Institute for Heath Technology Assessment

Low-Back Pain

Frequency, Management and Prevention From an HTA Perspective

DITHA's Summary and Conclusions
Members of the Panel

Introduction

Foreword

Low-back pain is one of the most frequent reasons for contact with the health care system. Low-back pain includes different conditions, and treat-ment should, therefore, be individualised. However, it is today acknowledged that the individual diagnosis and treatment offered to patients with low-back pain, is very varied. This variation is not always and only an expression of the fact that diagnostic and treatment are adapted to the individual patient.

On this background a number of national and international research projects have been made using a Health Technology Assessment (HTA) approach with the perspective to manifest today's knowledge on the problem and the most rational way to handle it.

In 1996, the Health Technology Assessment Committee of the Danish National Board of Health published "The National Strategy for Health Technology Assessment". One important strategy element is:

"Denmark will ensure, that international HTA initiatives are monitored and the results applied to the Danish National Health Service."

The background of the present report is to adapt international health technology assessments (HTA) into Danish conditions. The report consists of to volumes, where volume 1 is a survey of the extent of the problem in Denmark, and volume 2 is an evidence-based evaluation of different treatment methods and evidence-based recommendations for prevention diagnostics and treatment.

The report was made by a multidisciplinary working group, representing relevant professions in the Health Care sector.

DIHTA finds it of great value, that the multidisciplinary working group was able to agree both on a proposal for clinical guidelines for diagnosing patients suffering from low-back pain and recommendations on a number of different treatments and prevention.

It is DIHTA's hope, that the report will be well received and used by the different professions responsible for treatment as well as by the authorities with the managerial and economic responsibility for the health service in Denmark.

Statens Institut for Medicinsk Teknologivurdering
Januar 1999
Finn Børlum Kristensen

DITHA's Summary and Conclusions

Introduction

The purpose of this HTA is to adjust international technology assessments, already published on diagnosis, treatment and prevention of low-back pain, into Danish conditions, in order to improve a better decision making in the health care system.

Methods

A broadly composed working group of relevant professionals made this report as a result of a systematic consensus process based on a thorough evaluation of published scientific evidence and clinical expertise.

In the first place the quality of the scientific basis of using each individual technology was assessed - carefully guided by equivalent foreign HTA-reports. Based on scientific documentation the statements regarding the technology was evaluated on a 4-step scale. Based on estimates a graduation in three degrees was made of the expected economic consumption of resources that the use of each single technology would release.

In addition, the group suggested a recommendation/non-recommendation of future use of the individual technology. Explanations are linked to each recommendation, so it is clear under which circumstances the recommendation is valid.

Technology

A thorough examination carried out at the very first visit is the most important activity in the handling of the low-back pain patient. The main purpose of the clinical examination is to make a specific diagnosis and to exclude the existence of serious back diseases. Furthermore, it forms the basis for preparation of the most suitable programme of examination- and treatment for the patient concerned.

The past ten years' science has clearly shown that a patient activating treatment strategy, both for the acute and the chronic low-back pain patient is of great importance to ensure a stable effect of the treatment. For a successful treatment result a motivated participation chosen by the patient is important.

Organisation

Interdisciplinary agreements exist among the experts upon the following general principles on the organisation of care in the low-back pain area:

Irrespective of how the patient chooses to contact the health care system, it is important that examination and treatment procedures are the same.

All treatment should, if possible, take place in the primary sector and in the patient's own area. This is important in order to avoid unnecessary labelling of the patient and to avoid needless costs for the patient and/or to the health care system, as for example long transports.

Referral to specialist care or to a specialist centre should generally not occur before other relevant diagnosis/treatment in the primary sector has been tried.

Referral to specialist care or a specialist centre is recommended at once if alarming symptoms of back disease appear or if the patient does not recover within 4 weeks in spite of regular treatment in the primary sector.

Normally, patients with acute low-back pains are recommended not to consult emergency wards, as most of the emergency wards are unable to carry out a thorough evaluation of the problem.

In suspicion of bone fracture after trauma the patient is recommended to contact the emergency services.

Hospitalisation of patients with low-back pain is not recommended. Hospitalisation causes unnecessary labelling of the patient and often also a feeling of inactivity and loss of self-determination.

If serious back disease occurs e.g. bad pains, hospitalisation will often be necessary.

During the treatment course a close co-operation is important among the relevant professionals in primary care, for exchange of notes from case records (after permission from the patient is obtained), x-rays, treatment results etc.

Individual patient information during the diagnosis-/treatment efforts should always be a key activity.

The formal and informal routes of referrals should in general be kept unchanged.

The organisation of care should enable a division of work, which derives from professions' - by authorisation - defined business areas. This prevents or minimises the occurrence of multiple parallel episodes of care.

It should be ensured that the content of the individual treatment course is homogenous, irrespective if the patient consults his or hers general practitioner or chiropractor. Similarity in information given to the patient should be ensured, irrespective of the kind of practitioner that evaluates, informs and advises the patient.

Economy

Implementation of improved care programmes, besides causing savings at the budget in the health care system, will also bring about savings of public costs in areas such as transfer payments (sickness benefits and pensions). Overall factors in obtaining savings are:

To avoid costly waiting time.

To obtain the best possible communication and co-ordination between professionals involved and with other parties e.g. especially the social authorities.

To avoid that unnecessary or needless diagnosis- and treatment procedures are carried out.

DIHTA's Conclusions

If the documentation and recommendations of this report are followed, a range of treatments will definitively disappear from the health care system's handling of low-back pain, and more effective patient episodes of care will represent far a bigger fraction of cases.

In crucial areas implementation of the results of the report should go through interdisciplinary formed reference programmes and clinical guidelines. One obvious subject could be a reference programme with guidelines for the work out of "correct x-ray procedures"of the low back, carried out in co-operation with radiologists, surgeons, chiropractors, reumatologists, general practitioners etc. In addition reference programmes describing in which cases blood tests are necessary, should be worked out.

Economic aspects influence practice behaviour, and changes in collective agreements and contracts may cause great effect.

Broad implementation strategies that form a combination of printed material, (local, small-group based) problem oriented education, collegiate influence from opinion leaders, audit-feed back of actual treatment activity and visit by colleagues to the clinic is best suited in order to obtain changes in clinical behaviour. The working group was not asked to deal with future division of work between the caregivers. There is, however, a need for such a clarification, which could be made through discussions and negotiations with public agreement parties such as Sygesikringens Forhandlingsudvalg (The Board of Public Health Insurance).

It is important that the patient early in the treatment course takes an active part by receiving a thorough information. Information about the problem and treatment is most often repeated several times before the patient gets full insight into the matter. Individual information is recommended and should be based on the individual situation and need. A strengthened individual information effort towards the patient - both in the primary - and in the secondary sector - is an important aspect for the strengthening of future efforts. The collective agreements' possibility to promote this information effort should be analysed critically.

A shared patient record and electronic communication should be developed and tested so that the practitioners can share information about diagnosis and treatment already carried out.

Common and improved training of physicians, chiropractors and physiotherapists should be developed so the professions get a more equal approach to the individual patient and a technical language that is more common than it is today. These courses should also include other relevant professional groups such as teachers of relaxation and psychologists. Relevant professional academic environments should support the training.

Particular courses for social-/rehabilitation staff should be given higher priority than it is in the care today. The newest well-documented professional know how should also form the basis for decisions about social measures for patients with low-back problems.

The professional groups' thorough work has revealed a big need for a broad scientific effort in the field of clinical science research and health services research. Methodological competence at high levels is necessary for valid and reliable results. There is, therefore, a need for supporting academic centres, which are willing to undertake education of scientists and methodology advisers.

The evidence basis for decisions on treatment is regularly changed. Thus, the low-back pain-report must be updated after four years at the latest, in order to preserve its relevance.

Members of the Panel

This manuscript is the result of work carried out by a panel which was appointed by the Health Technology Assessment Committee of The Danish National Board of Health. The manuscript was compiled by Claus Manniche.

Professor, Chief Physician Claus Manniche MD, (Chairman)*

Economic Affairs Anni Ankjær-Jensen*

Assistant manager Anni Olsen*

Relaxation Therapist Anni Fog

Danish Relaxation Therapists

Physiotherapist Kirsten Williams

Danish Physiotherapy Aassociation

Chief Physician Finn Biering-Sørensen

MD, Danish Epidemiologic Society

Peter Kryger-Baggesen, DC

Danish Chiropractors Association

Chief Physician Claus Mosdal, MD

Danish Society of Neurosurgeons

Hospital Director, Chief Physician Hans Christian Thyregod, MD

Danish Society of Orthopaedic Surgery

Chief Physician Erik Martin Jensen, MD

Danish Rheumatological Society

Niels-Frederik Pedersen, MD

Danish Society of General Medicine

Chief Physician Svend Lings, MD

Danish Society for Occupational and Environmental Medicine

Chief Physician Lars Remvig, MD

Danish Society for Musculoskeletal Medicine

Professor, Chief Physician Tom Bendix, MD

The Arthritis Association

* Members appointed by the Health Technology Assessment Committee of The Danish National Board of Health.

Protocol records:

Per Bülow, MD
Kim Upperup, of the Center for Health Services Research and Social Politics, University of Odense, has participated in the production of the Appendix and Appendices A,B, and C.

Introduction

Foreword

In the spring of 1995 the Health Technology Assessment Committee of The Danish National Board of Health (HTA) appointed a working group which was called the "Low-back pain group" (LBP-group). The task of the LBP-group was to adapt published international HTA reports regarding the diagnosis, treatment and prevention of "low-back pain" to Danish conditions.

Low-back pain has such a high prevalence in the general population that an episode should almost be classified as a normal occurrence. Every fifth Dane will experience low-back pain during a fourteen-day period. This result in a great utilisation of treatment, sick-leave, and in many cases health related disability pensions.

The LBP-group was comprised of individuals representing the different professional associations that deal with low-back pain and also included a representative from a musculoskeletal patient association. Individuals with expertise in administrative and economical affairs related to the hospital sector were also included. The scientific societies from different medical specialties that are involved with the examination and treatment of low-back pain each appointed a representative to the LBP-group.

In the fall of 1996 the LBP-group delivered the report entitled "Low-back pain- a delineation of the problem, prevalence and suggestions for its management" to the committee, whereupon it was published by the National Board of Health. In this manuscript the initial report will be termed Low-back pain Volume 1. This report has been sent out to those responsible for political decisions, health professional organisations as well as their members in the Danish health care sector. The first volume was published in 8000 copies.

In 1997 the Danish Institute for Health Technology Assess-ment was formed, and the responsibility for concluding the work was placed here. The LBP-group continued its work until the present report was completed after holding 31 meetings until August 1998.

The LBP-group has carried out its work in an objective manner and has demonstrated a willingness to look closely at the entire area under investigation without political interference. The LBP-group has reached agreement on all important issues. There has been some divergence of opinion as regards a few minor details. The report is written without the use of too many professionals’ terms, as was the case with Low-back Pain, Volume 1. The LBP-group has attempted to write a report that can inspire both politicians and professional decision-makers that are associated with the health care sector.

With the publication of this report, the LBP-group's work assignment according to the original commission is completed.

Health Technology Assessment and Source Material

Health Technology Assessment is a thorough, systematic evaluation of the indications and consequences of utilising medical technology. Technology refers to any method used in arriving at a diagnosis, treat-ment or prevention. HTA includes an evaluation of a series of elements which can be classified into the following 4 headings:

Technology (treatment method),
The patient
Organisation and
Economic

The LPB-group has at certain times retrieved literature in order to clarify certain areas but has for the most part used the following national and international Consensus -/HTA-reports as the basis for its recommendations.

Back pain- causes, diagnosis and treatment (pages 1-122). Statens Beredning för Utvärdering (SBU), Stockholm 1992, Alf Nachemson, report nr. 108, pp 1-122. This publication was a thorough review of the entire subject including the documentation of different treatments as well as future strategies.

Acute low back problems in adults Agency for Health Care Policy and Research, Public Health Service, Rockville, U.S. 1994. This project included a thorough and systematic review of the available literature regarding treatment. The report has been published in a user-friendly fashion and can be used as a reference text. The different treatments have been graded according to scientific documentation so that the reasoning behind their recommendations is clear.

Musculo and Skeletal disease in Denmark. Danish Institute for Clinical Epidemiology (DICE), 1995. The report is a population based survey of the frequency of musculo and skeletal diseases in Denmark. The survey is based on interviews with 4818 danes between September 1990 and May 1991.

Report on Back Pain. The Clinical Standards Advisory Group, London, 1994, pp. 1-47. The epidemiological review is particularly thorough.

Consensus report: Low back pain. The Danish Society of Internal Medicine, Ugeskrift for Læger;1996:suppl 4; 1-18. This report is a concise and systematic review of the subject. The emphasis was on diagnosis and treatment of the most common acute and chronic low back diseases

Clinical Guidelines for the Management of Acute Low Back Pain
Royal College of General Practitioners, London 1996, pages 1-35. Organisations contributing to this report included: general practitioners, physiotherapists and chiropractors. The report includes practical guidelines based upon the "Report of back pain", see above.
Conservative treatment of acute and chronic non-specific low-back pain. Van Tulder MW et at. Spine 1997;18:2128-56. This "evidence based" medical evaluation of the most commonly used treatment forms for low-back pain was written by a research team from the University of Amsterdam.

If another source has been used this will be referred to in the text. Figures and Tables are always given with references. As far as was possible reference material representative of the adult Danish population was used.

VOLUME I

LOW-BACK PAIN

1. What is "low-back pain"?

Definition

In this report, "low-back pain" is defined as tiredness, discomfort, or pain in the low back region, with or without radiating symptoms to the leg or legs. In the remainder of this text these symptoms will be referred to as low-back pain. The definition does not take into consideration either the duration or the degree of symptoms. Anatomically the low back is to be considered the area from the lowest rib and downward to the bottom of the sitting muscles as illustrated in Figure 1.

/ILLUSTRATION: Figure 1 Shows upper and lower regions of the low-back/

This definition does not differ markedly from those used in other international HTA-reports. The British report only recognises symptoms of more than 24 hours duration.

Diagnoses commonly used in clinical practice include: lumbago, facet syndrome, sciatica, disc herniation, muscle tension, crooked or curved spine, degenerative arthritis, osteoporosis, and so forth. These "diagnoses" may cover a specific condition (osteoporosis or disc herniation) but for the most they cover a range of symptoms.

The report includes data on people with low-back symptoms of shorter or longer duration. The term acute symptom is to be understood as symptoms lasting less than three months. All symptoms lasting more than three months are considered as chronic symptoms. In accordance with the international HTA-reports we do not use the term sub-acute symptoms in this report. This term is difficult to limit in terms of time and has no particular diagnostic or treatment relevance.

Incidence of low-back pain in the historical perspective

Discomfort and pain in the low-back was first described on paper in 1500 BC by Edwin Smith's papyrus writings. Prior to the 19th century the possible relationship between the facet joints, the discs, and nerve irritation and low-back pain was unknown. However, the relationship between fractures and deformities had been known for a long time.

In the 20th century it was quickly established that the nervous system could be involved in the development of low-back pain and later on it was widely accepted that low-back pain was possibly caused by an "irritation" of the nervous system. Due to the difficulty in establishing a physical cause many of the symptoms were considered to be of an hysterical (psychological) nature. The most commonly held belief was that symptoms were a result of an irritated nervous system and research focused on this area.

In conjunction with the development of the British railway system (1800-1850) a relationship between heavy work and damage to the back was acknowledged. Prior to this time low-back pain was never seen in association to an injured spine. The term "wear and tear of the back" became accepted and individuals were entitled to compensation in some instances. Research activity in this field increased markedly but it was still not possible to establish a direct cause and effect relationship.

During this time, the medical speciality orthopaedic surgery was developed. As regards low-back pain, bed rest was the most commonly prescribed treatment. Low-back pain was not treated with bed rest in earlier times, but was considered to be a valid treatment in this period as symptoms appeared to improve in many patients. The use of bed rest was not based upon scientific documentation but rather on empirical evidence (experience). Current knowledge dictates that it is both wrong and clinically ineffective to treat almost all low-back ailments with bed rest of up to several weeks' duration.

In 1934 it became clear that the bulging of discal material could result in pressure on the spinal nerves which could in turn result in loss of muscular function and sensory disturbances. This groundbreaking new knowledge regarding the pathoanatomical relationships of spinal structures unfortunately led many physicians to believe that all spinal problems were discal in origin. Many were therefore of the opinion that surgery would be the answer for most back ailments. As great advances were being made in anaesthetics and surgical specialities during this period many low-back pain patients underwent surgery; many of them up to several times. The tendency to overutilise a newly developed treatment modality for a period of time has also been seen in other areas of medical science.

The use of long-term bed rest resulted in increased illness behaviour for low-back patients, which also resulted in physical de-conditioning. Many patients became worse off due to bed rest than they would have been otherwise. Additionally, many patients underwent surgery in spite of uncertain pathoanatomical findings. These and other factors may have led patients with ordinary low-back pain on a journey ending with severe disabilities.

During the past 30 years much energy has been focused upon reducing workloads as a result of the increased number of low-back pain episodes occurring at the work place.

Many preventative measures have been undertaken in order to prevent repetitive work and heavy lifting at the workplace. In spite of these measures the incidence of low-back episodes at the work place continues to rise. This development underscores the multi-factorial nature of low-back pain, which includes socio-economic factors as well as work conditions.

The prevalence of low-back pain in Denmark

Low-back pain is among the most common painful conditions in the Danish population. If questioned directly, thirty-five per cent of the population will report that they have experienced low-back pain (either short-lived or persistent) during the past year while twenty-one per cent will have experienced back pain during the past fourteen days (Table1). Females report a greater frequency of low-back pain than males however the percentage of disc herniations and long-term low-back disability is very similar for both genders.

Table 1
Percentage of males and females with various low-back problems in different age groups?

Males Females

Percent with: 16-24 25-44 45-66 67+ Total 16-24 25-44 45-66 67+ Total M+F

Back pain within the past year *) 34 42 40 24 38 41 42 45 37 42 40

Low-back pain during the past year 27 36 35 22 33 34 36 41 34 37 35

Daily back pain during the past year *) 2 6 11 11 8 6 8 15 20 12 10

Back pain during the past 14 days *) 12 19 21 16 18 18 21 26 27 23 21

Disc herniation during the past year - 1 3 1 2 - 1 3 3 2 2

Other back diseases during the past year 9 15 19 9 15 11 11 21 16 15 15

Long-term disease 3 7 11 7 8 4 5 15 9 8 8

# of interviewed people 378 923 693 311 2305 388 947 738 440 2513 4818

*) Back pain in this row is to be considered as both upper and/or lower back pain but not neck pain. Ref. DIKE 1991.

As far as age in concerned there is a weak increase in frequency from ages 16 to 67 whereupon a decrease in frequency takes place for both genders, but the decrease is not as great for females. In all likelihood this is due to osteoporosis which is commonly observed in females of this age group.

The British "Report of back pain" documents that the number of sick-leave days due to low-back pain has increased three-fold during the past fifteen years. The newest data from Denmark also point to a further increase compared to the data used in this manuscript.

The most frequently reported painful region of the spine is the low-back (28%), while pain in the upper spine or both the upper and lower regions of the spine are not as common (Table 2). There is no difference between genders as far as spinal pain localisation is concerned (Table 2.)

Established causes of low-back pain

In this section "causes" should be considered as objective findings such as; x-ray findings and blood tests which may explain the symptoms. Factors such as heavy lifting or repetitive work (external factors) are not considered even though they may influence low-back symptom development.

We are aware of a wide variety of diseases/conditions, which can contribute to or cause low-back pain but even after a thorough examination it is not possible to make an accurate diagnosis in 70-80% of patients. In the remaining 20-30% a diagnosis can be made on the basis of objective findings which cannot be found in healthy individuals. There is however an element of uncertainty with this latter group as well. It has been demonstrated scientifically (CT-scanning) for example, that between 25% and 75% of healthy individuals have positive findings suggestive of disc herniations. Degenerative changes in the spine as seen on plain x-rays should be considered as a part of the natural ageing process. Approximately fifty per cent of all people over fifty years of age have degenerative changes but the incidence of low-back pain is equivalent in people either with or without spinal degeneration.

Social and economic factors

There are no specific data regarding the influence of social and economic factors and low-back pain for the individual but musculoskeletal disease is the most common cause of decreased daily activity, sick-leave and disability pensions (Table 3.)

The lower back is the most frequent problem area of the entire musculoskeletal system, and as such we can use the data from the entire group. Similar data can be found from other Western countries which we normally compare ourselves.

In Denmark, more than 120,000 hospital days as a result of disc and other vertebral lesions were documented (Table 4). In addition to this, a large patient group exists with more diffuse symptoms such as osteoporosis, or referred pain from other organs. According to the Ministry of Health's figures from 1993 the total number of hospital days due to somatic disease in Denmark was 7.5 million. The group including spinal disease, disc herniation, osteoarthritis as well as other related illnesses was calculated to be 330,000 days per year. This number equals the yearly hospital day capacity of one of the largest hospitals in Denmark.

Tabel 4
Number of hospitalisation days for chosen diagnoses in Denmark 1994.

Diagnosis Discharged
÷ operation # of days at hospital
÷ operation Discharged
+ operation # of days at hospital
+ operation

Lumbar disc herniation 4778 43566 2880 26828

Degeneration of discs or bones in the low-back 1682 16938 498 5709

Low-back pain without signs of disc herniation 2696 25319

Reference: National patient registry, Ministry of Health 1995

The number of hospital days used for back illness has remained fairly constant from 1983 to 1993 in spite of the fact that it has been shown that hospitalisation for most back conditions has been shown to be unnecessary or even contributory regarding the promotion of illness behaviour. At present there are no separate numbers as regards costs regarding low-back pain patients as opposed to the overall group of musculoskeltal patients. The possibility of arriving at precise public health costs associated with low-back disease is made difficult by the fact that certain disease costs are not classified singularly. For example, services provided in the primary health care sector are not registered systematically (how many patients, what type of treatment, which diagnoses?). It is also difficult to calculate the exact public costs associated with sick-leave and disability pensions directly related to low-back disease alone, because many patients are unable to work for differing periods of time due to several competing diseases which may be present simultaneously. In our group we concluded that it was impossible to acquire more precise data without initiating several costly analyses.

Indirect costs can be evaluated by using data from the whole disease group "musculoskeletal diseases." Table 5 shows both the direct and indirect costs of 13 chosen disease groups. Only psychiatric diseases are more costly to society than muscoloskeletal disease. The numbers cover the entire musculoskeletal disease area and as previously stated low-back disease contribute approximately 50% of the costs of this disease group. The yearly costs to society are therefore roughly 10 billion Dkk. Note that the direct costs of this group are less than several of the other groups. However, the large indirect costs result in the great total costs related to this disease group. We conclude that considerable savings will mainly come from reducing the indirect costs. (Table 5.)

2. Illness Behaviour

Illness behaviour includes all forms of reactions resulting from signs and symptoms of a disease. Examples include conscious inactivity, self-treatment, and seeking help from health professionals as well as from friends and family.

Many individuals (approximately 30%) suffering from musculoskeletal symptoms do not alter their activities of daily living nor do they seek help in the form of treatment (Table 6). There is no data in the DIKE report which deals specifically with low-back pain, however, it is unlikely that this group differs from individuals suffering from other forms of musculoskeltal pain.

Table 6
Illness behaviour among males and females in different age groups suffering from musculoskeletal symptoms during the past 14 days given in percentages (%)

Males Females

16-24 25-44 45-66 67+ Total 16-24 25-44 45-66 67+ Total M+F

Has done nothing 42 34 33 42 36 29 21 22 35 25 30

Self-treatment only 44 50 51 47 49 60 62 62 47 58 55

Self-treatment and sought professional care 9 12 15 7 12 8 14 13 13 13 12

Only sought treatment 4 3 1 4 3 3 2 3 6 3 3

In total 100 100 100 100 100 100 100 100 100 100

Source DIKE 1991

A large group attempt to tackle their low-back pain problem by altering work patterns, changing the ergonomics of their work-stations, or by participating in preventative fitness training programs (Figure 2, page 25).

Figure 2
The percentage who attempt different things in order to reduce symptoms due to musculoskeletal trouble

/ILLUSTRATION: Figure 2/

Individuals suffering from severe pain or disability will naturally seek help from health professionals at greater rates than others. (Table 7). There is therefore, a clear relationship between pain intensity and treatment although approximately 68% of individuals suffering from severe pain do not seek treatment even though 88% of these individuals do not believe that their symptoms will subside.

Table 7
Percentage of differing illness behaviour among people with different types of musculoskeletal symptoms given in percentages (%)

With severe pain With reduced activity levels Are not capable of doing what what they would like to Have symptoms from several areas of the body Tired due to symptoms Have had symptoms for a longer period of time Do not expect that their symptoms will resolve

Has done nothing 14 20 24 25 21 30 32

Self-treatment only 54 49 52 57 55 56 56

Sought treatment (and eventually did something themselves) 33 31 24 18 24 14 12

In total 100 100 100 100 100 100 100

Source DIKE 1991

Twenty-three per cent of individuals suffering from low-back pain that seek professional help will initially contact their general practitioner. A group (12%) will seek help from a chiropractor either separately or at the same time that they contact their general practitioner. Slightly less than fifty per cent will be referred to a physio-therapist (9% of all patients seeking help). Only a small percentage will be examined and treated by a specialist in rheumatology or at a hospital. The vast majority of treatment is provided in the primary health care sector by general practitioners, physiotherapists or chiropractors (Table 8).

Table 8
The number of consultations with health professionals during the past year and the number of treatments from all individuals suffering from low-back pain.

Percentage with contact Average number of contacts Number of treatments*

General practitioner 23 3,5 417.000

Physiatrist or rheumatologist in private practice 4 6,5 135.000

Doctor at a hospital department 4 4,0 83.000

Physiotherapist at a hospital 4 8,4 174.000

Physiotherapist in private practice 9 11,7 545.000

Chiropractor 12 6.5 404.000

Total number of treatments

1.758.000

The same person can have received treatment from several health professionals.

*The number of treatments is derived from the fact that there are 4 million Danes over the age of 16, of which 35% have had trouble with back pain during the past year and 37% of whom have sought treatment.

Source DIKE 1991

Thirty-seven per cent of individuals suffering from low-back pain will seek treatment within a year (DIKE 1995). The percentage of individuals that seek care due to low-back pain related functional disabilities are greater than those suffering from other diseases of the musculoskeletal system (10-20%). This can be interpreted to mean that low-back pain related symptomatology is perceived as requiring more treatment than other diseases of the musculoskeletal system.

35% of the Danish population report having low-back pain during the past year

37% of individuals with low-back pain seek treatment

The number of sick-leave days has been increasing the past 20-30 years

At the present time there is no scientific evidence that low-back trouble has changed character. The increase in the number of back complaints must therefore be a result of changed work or psychosocial aspects

Low-back pain results in a total cost to society of over 10 billion DKK

3. Risk factors (indicators)

Risk factors relates to factors that have a probable influence regarding the development of as well as the course of low-back pain, but should not be confused with a cause and effect relationship which requires secure knowledge regarding a direct relationship between an injury resulting in low-back pain. The scientific literature in this area is rather unclear both regarding the clear definition of the involved terms as well as the statistics employed. For example, many risk factors have not been examined as far as their relationship to one another is concerned. Utilising the term factors can therefore result in misunderstandings while the term indicators (to be a sign of, to represent, or to reflect) more accurately describes our concerns. Generally the term factors is more commonly used in the literature and we will follow suite in this report.

Our knowledge regarding possible risk factors has been derived from large population studies where a statistical correlation between risk factors and low-back pain in the studied population has been frequently demonstrated. The relationships are very complex due to the fact that many factors have to be evaluated at the same time. Additionally, unknown factors may play a role in the development of low-back pain as may factors that have not been recorded.

Results from research may present conflicting conclusions. However, for a number of factors there is solid documentation of a relationship between exposure and the general development of low-back pain. The degree and duration of exposure will influence both the development and the course of low-back pain.

Traditionally, risk factors are divided into individual and external groups. Furthermore, there are factors, which contribute to the development of chronicity. Individual factors are related to the person in question, while external factors most often relate to work or social fac-tors. However, a clear separation of these factors is not always possible. Similarly, risk factors regarding the development of acute and chronic low-back pain oftentimes overlap. This can be seen in Figure 3, where there is no clear separation between the different risk factors.

A series of different factors are important as regards the frequency as well as the duration of low-back pain for the individual person. Oftentimes, several risk factors (both known and unknown) acting simultaneously will affect the course of low-back pain and it can be impossible to determine which of the factors is the most important.

In Figure 3 a series of risk factors are presented under the heading "proven". These factors are regarded by most experts as being most frequently involved in the development of low-back pain, but they should not be regarded as obligatory. At the present time it is not possible to propose a list, ranking the most important factors.

Figure 3
Possible and proven risk factors regarding the development of low-back pain
Possible will be presented in normal font, while proven will be given in bold type.

/ILLUSTRATION: Figure 3/

We cannot for example conclude that "heavy lifting" contributes more frequently to the development of low-back pain than either "psychological stress or low social status".

In the future, it will be of great importance to study risk factors responsible for the development of chronic low-back pain because this oftentimes results in patients being sick-listed for several years, receiving endless amounts of treatment, and ending with permanent dis-ability pensions. Risk factors of importance as far as this issue is concerned include: long-term sick-listing, exaggerated illness behaviour, stress or depression, low levels of job satisfaction, smoking, and on-going litigation/pension procedures.

During the course of the last twenty years, decision makers as well as the population at large have been led to believe that back-pain is most often due to many years of heavy lifting or inappropriate seating postures. This has logically resulted in preventive measures being undertaken at the workplace aimed at reducing the pace of work as well as the number of heavy lifts. During this period, the number of people suffering from low-back pain has unfortunately increased markedly. This is in all likelihood due to the fact that only some of the cases of back-pain are mainly work-related. A great number of low-back complaints are a result of other social as well as individual factors.

Among the HTA participants there is agreement that "individual factors" are at least as important regarding the development of low-back pain as are the external factors. It is essential that in future preventive activities, all known risk factors be addressed (both individual and external).

Individual risk factors are at least as important regarding the development of low-back pain as are external factors

Future preventive measures must address both individual and external factors

4. Diagnostics

Diagnoses

During the years many different diagnostic classification systems of low-back pain have been devised in order to arrive at a likely diagnosis. Emphasis has either been placed upon the anatomic localisation, causes or symptoms. None of these attempts at classifying patients has been comprehensive enough to cover the wide spec-trum of low-back pain.

It has become accepted in professional circles that it is impossible to make a specific diagnosis in approximately 70-80% of cases regardless of how thorough the examination procedures have been. Due to a lack of solid biological causes the terms "non-specific back pain" or "simple back pain" have become widely used.

Non-specific low-back pain is divided into the following classifications, which are based upon patient symptom description. These divisions have been shown to be of value regarding the health professionals' need of further examinations and treatment strategy design.

Acute low-back pain

Chronic low-back pain

Acute low-back pain with radiating symptoms to the lower extremity

Chronic low-back pain with radiating symptoms to the lower extremity

Certain diagnoses can however be based upon a pathoanatomical basis. This of course depends upon a clear correlation between anatomical findings and patient symptoms. This is possible in approximately 30% of low-back pain patients.

Degenerative low-back conditions. This term covers a variety of conditions including spondylosis, disc degeneration/herniation, spondyloarthrosis, and is generally considered to imply degeneration taking place somewhere in the spine. Spinal degeneration is a natural phenomenon, which can commence at different periods of an individual's life. Severe degeneration of the spine can result in either constant or periodic pain. Our present knowledge regarding the biological mechanisms of spinal degeneration and their relation to spinal symptoms is very sparse.

A overview of diagnoses in which there is a correlation between observed findings and symptoms

Degenerative Conditions:	Other:
Spondylosis/disc degeneration at several levels	Scheuermann's Disease
Spondyloarthrosis	Discitis
Disc herniation	Infectious spondylitis
Spinal stenosis	Osteoporosis
	Spinal tumors

Spondylosis/disc degeneration (osteoarthritis of the bones or discs) can be identified with the following x-ray findings: Reduced discal height, sclerosis of vertebral bodies or calcification of the discs. X-ray findings usually correlate poorly with symptoms. Even severe degenerative findings do not necessarily result in symptoms.

Spondyloarthrosis (degeneration of the true joints of the spine) refer to degenerative changes of the facet joints between the vertebra. Due to the anatomy of the region there is a poor correlation between joint degeneration and pain localisation. It has been shown experimentally, for example, that facet joint irritation can result in gluteal pain. Spondyloarthosis usually develops as a result of reduced disc height.

Disc herniation is commonly associated with low-back pain in the general population. Symptoms result from the nucleus of the disc pressing on the spinal nerves and/or resulting in a chemical irritation of the nerves due to tears in the discal fibbers. These nerves are a part of the sciatic nerve. Symptoms can vary according to the level of the disc herniation, however radiating pain to the leg and weakness of the foot are frequently observed. Disc herniations can also be found in individuals that have no symptoms at all. In spite of the oftentimes dramatic course of events in the acute phase of a disc herniation, the long-term prognosis is most often favourable. Only one out of four patients require surgery.

Spinal stenosis refers to a condition with reduced space in the spinal canal due to degenerative changes. In conditions, which result in symptoms due to pressure on the nerves, the most usual symptoms are pain and decreased strength in the legs. Symptoms usually develop after a period of time.

Scheuermann's disease occurs in the growth zones of the vertebra. This results in an alteration of the shape of the bodies of the vertebra from the classic block-like form to a wedge form. This process takes place during puberty and is more commonly found in males. This disease is most commonly seen in the thoracic spine (chest) although it can also be found in the low-back. Symptoms resulting from a thoracic Scheuermann are rare whereas symptoms from the low-back are more frequently (but not always) observed.

Arcolysis is a defect in the part of the bone that connects the facet joint to the vertebral body. This is a common finding in 5% of the adult Danish population and can be found in 35% of the Eskimo population. This condition does not necessarily result in pain. If however, a spondylolisthesis results in a vertebra slipping forwardly on the vertebra below symptoms may develop. This condition can also be found as a result of degeneration of the disc or facet joints.

Scoliosis is a condition with unusual curves of the spine in the side plane which can be a result of unequal leg lengths (non-structural) in as much as 20-30% of the population. However, scoliosis may also be a result of changes in the vertebra, muscles and connective tissues. In younger people scoliosis is due to a developmental defect while in older individuals it is oftentimes seen in association with degenerative changes in the spine.

Discitis is an inflammatory condition (sometimes bacterial) in the discs of the spine. It most frequently results after surgery (1-2%).

Infectious spondylitis is a bacterial inflammation localised to one or more vertebrae. The bacteria usually spreads through the blood. This disease is usually found in individuals with weakened immune systems, among the elderly, in individuals with systemic disease (diabetes), or in drug abusers. Initial symptoms include fever and back pain. It is characterised by extreme tenderness to pressure of the adjoining vertebrae.

Sacroiliitis/Ankylosing spondylorarthritis is an inflammatory process in the joints of the pelvis and the sacrum as well as in the joints of the spine. This process can be found in conjunction with other arthrotides or independently.

Osteoporosis refers to a lack of calcium in the bones resulting in changes in structure which may result in fractures after seemingly minor trauma. Osteoporosis is most frequently seen in elderly females due to decreased estrogen production after menopause. This results in a negative balance in the process of during which bone tissue is renewed and torn down.

Spinal tumors include both benign and cancerous tumors. Primary spinal tumors are quite rare and most are a result of metastasising cancer from either the lungs, breasts, or bladder. Most patients are from 50-60 years of age but tumors can be found in all age groups. Symptoms include pain, which is oftentimes worst at night, weakness and sensibility changes in the legs. The course can be either slow or quick depending on the localisation of the tumor.

5. Diagnostic Procedures

For most patients suffering from low-back pain a thorough interview and clinical examination will suffice. These procedures will reduce the likelihood of there being an underlying pathology, which is causing the low-back pain in either acute or chronic low-back pain. The interview includes a thorough round of questions regarding how and when the pain developed as well as the course of the symptoms. Information regarding previous episodes of low-back pain is also relevant to discuss. A comprehensive review of potential risk factors regarding the development of chronic low-back pain is also of extreme importance.

The interview is followed by the clinical examination. The primary purpose of the clinical examination is to attempt to make a specific diagnosis as well as to make sure that there is no serious illness present, which may require further examination. A thorough examination is also necessary in order to determine the most appropriate treatment strategy for the patient and to avoid unnecessary repetitive examinative procedures.

In the opinion of the HTA group, the initial examination is the singularly most important activity as regards the management of the low-back patient. If properly carried out one can evaluate the magnitude of the patients problem, determine if additional examinations are necessary and initiate treatment. It may also be possible to weigh the risk of chronic symptom development and to initiate preventive measures.

The clinical examination should include a relevant number of the diagnostic tests, which are described below. A particular problem is the differing attitudes regarding the validity and interpretation of certain clinical tests both intra- and interprofessionally. This often-times results in patients receiving contradictory information.

The clinical examination

Postural anomalies (curved spines)

Spinal motion

Gait analysis

Pain tests (tenderness of the spine)

Lasegue's test (straight leg raising)

Neurological tests (sensibility, reflexes, strength)

Rectal examination

Para-clinical tests (x-ray, blood)

Imaging (X-ray, CT and MRI-scans) and spine diagnosis
Traditionally, a x-ray of the spine is one of the first examinations undertaken in low-back pain patients. However, this examination for the most part does not provide any meaningful information for the majority of patients, as x-ray findings generally correlate poorly to symptomathology. Additionally, x-ray findings rarely provide useful information regarding the course of the problem such as the risk of developing chronic symptoms.

Only in circumstances where the health professional suspects the pre-sence of infection or other inflammatory conditions, fractures or cancer will x-rays provide information of importance regarding further examinative procedures and treatment.

It is the opinion of the HTA group that x-rays should only be generally entertained if the low-back pain has been present for at least four weeks. Ordering x-rays earlier in the course of events is not ethically or economically acceptable. Only in circumstances where the health professional is led to believe that other diseases may be present can the above conclusions be circumvented.

One should attempt to secure previously taken x-rays (1-2 years old) at the initial consultation and to make sure that patients have their x-rays with them if referred to other health professionals in order to prevent unnecessary x-ray exposures and delays. The reason that x-ray examinations are oftentimes repeated is that they cannot be retrieved quickly enough or due to poor quality. The HTA group strongly recommends that guidelines for "proper x-ray procedures" for low-back patients be prepared. This can be done through co-operation between radiologists, surgeons, chiropractors, rheumatologists and so forth. It is also necessary to evaluate the best method of storing x-rays so that health professionals can retrieve them as quickly as possible so that treatment strategies are not delayed.

More advanced imaging such as CT and MRI -scans (with or without contrast fluids) are rarely indicated in acute low-back pain for the same reasons as mentioned above. Scanning procedures should only be entertained if patients are experiencing functionally disabling symptoms such as severe back or leg pain for more than month and/or if surgical is likely.

The x-ray procedure involving the injection of contrast fluids in the spinal canal (myelography) is still commonly used in hospitals even though the information provided is similar to that of other procedures. Myelography is not used as frequently as in previous times due to the risk of pain development, severe headache (days to weeks) and the slight risk of infection. The HTA groups suggest, in accordance with international trends, that less invasive procedures such as CT or MRI scans be used as the standard procedure in the investigation of disc herniations as opposed to myelography. In cases where there is a suspicion of spinal stenosis (narrowing of the spinal canal) myelography may be the procedure of choice.

The costs of these different procedures varies from place to place, with x-rays ranging from 375-1000 DKK myelography 2500 DKK, Ct-scans 4000 DKK and MRI-scans 7000 DKK.

These figures do not include costs associated with treatment and eventual side effects.

Considerable amounts can be saved by avoiding unnecessary examinations or repeated examinations and if these procedures are (as far as is possible) initiated only if surgery is being entertained.

Blood tests

In the vast majority of cases of low-back pain it is not necessary perform a blood examination. Indications for blood tests include suspicion of infection, other inflammatory processes or malignancies. The type of blood tests required will depend upon information gathered from the interview and clinical examination. The following blood tests will be sufficient for initial diagnostic considerations: Hemoglobin (blood percent), white blood cell count, serum creatinine (kidney function), serum calcium (bones), basic phosphates (bones), and blood sedentary rates (general sickness indicator). Additionally, it may be relevant to examine the urine for blood and white blood cell counts if there is any suspicion of urinary disease. If the above mentioned tests are all negative it is highly unlikely that low-back symptoms are a result of any inflammatory process or other metastatic disease.

The HTA-group recommend that reference programs including guidelines as to what blood tests should be done and in which circumstances. Superfluous examinations are not only expensive but they also are associated with promoting illness behaviour and inducing unnecessary fear on the part of patients.

Prices for the individual blood tests cannot be given because the cost of equipment is far greater than costs associated with carrying out individual tests. Therefore, the cost of singular tests is dependent upon the total number of tests that are done. Total costs will only be reduced minimally if the number of examinations are fewer and conversely will only increase markedly of the number of tests ordered increases dramatically resulting in the purchase of additionally equipment and the hiring of additional personnel.

In 70-80% of cases it is only possible to arrive at the diagnosis "non-specific" low-back pain, even after a thorough examination
A diagnosis based on a secure pathoanatomical foundation can only be made in 20-30% of cases
A diagnosis can only rarely predict the course of the disease
A relevant and comprehensive interview and clinical examination should always be undertaken during the first consultation with a health profes-sional
Diagnoses can only in rare situations be arrived upon on the basis of imaging techniques or blood tests alone
X-ray examinations of the spine should only be undertaken if there is a suspicion of an inflammatory condition, a fracture, a malignancy, or if pain continues for more than 4 weeks

6. How Do We Address the Low-Back Problem From An Organisational Standpoint?

A considerable increase in the utilisation of both authorised health care professionals as well as alternative practitioners in the past years is in all likelihood due to a variety of factors including: Our present lack of diagnostic capabilities, the unwillingness of individuals to "accept" pain, and the widespread practice of undocumented treatments. Due to a lack of co-ordination in the authorised health care system many "services" are repeated. For example, a patient may be consulting a chiropractor and a physiotherapist at the same time without any communication between these professionals taking place. X-rays may be taken at the chiropractic clinic and ordered from the regional hospital at the same time. This lack of co-ordination results in inappropriate patient strategies, unnecessary costs, and the promotion of illness behaviour.

The present health care system
At present, the health care system is composed of primary and secondary sectors. Figure 4 present the structure of the system as well as the placement of the different health care professions. In the Figure, formal referral routes are presented with arrows and informal referral routes are presented with dotted lines. Patients can be examined and treated by general practitioners and chiropractors with support from the National Health Care insurance. Patients receive financial support from the national health care insurance when being examined and treated by physiotherapists and specialists, only when referred by a general practitioner

Treatment at hospitals is also dependent upon a referral from a general practitioner, a specialist or a physician on call. Two-thirds of individuals suffering from low-back pain consult their general practitioners initially and one-third contact a chiropractor (Table 8, page 24). The selected health professional is responsible for the manner in which the patient is taken care of initially.

Suggestions for the future organisation of low-back pain assessment and treatment
The HTA-group is in agreement regarding the following recommendations regarding the organisation of the manner in which low-back pain should be handled.

Irrespective of whom the patient consults, examination and treatment strategies should be the same.

Treatment should be carried out in the primary health care sector and preferably in the region where the patient lives. It is important to avoid unnecessary waiting times, the promotion of illness behaviour, and unnecessary costs due to factors such as distance.

Referrals to specialists should not be undertaken prior to comprehensive assessment and treatment in the primary health care sector.

Referral to a specialist or a hospital department should take place quickly if there are signs of serious disease or if patients do not improve in spite of a 4-week trial of recommended treatment in the primary health care sector.

We recommend that as a rule patients not seek care at hospital emergency wards due to acute low-back pain because most acute wards are not geared to handle this type of problem.

Generally, patients should not be hospitalised due to low-back pain. Hospitalisation increases the likelihood of promoting illness behaviour due to patients' lack of control over the situation. Inactivity is promoted and costs are high.

In circumstances of serious illness and extremely severe pain, hospitalisation is of course recommended.

During treatment close co-operation between relevant health care professionals for example exchanging journals (with patient permission), x-rays, treatment results and so forth.

Individual patient information is always a central aspect of assessment and treatment.

In the opinion of the HTA-group, both the formal and informal referral channels presented in Figure 4 should be upheld. The organisational planning of low-back pain treatment and assessment should be carried out in accordance with the scope of practice of authorised health care professionals. This is the only way to minimise the duplication of services. We have concluded that a more thorough evaluation of the future roles of the differing health professional is not a part of the HTA-commision.

Figure 4
Present health care sector

/ILLUSTRATION: Figure 4/

There are two ports of entry to the public health care system regarding the treatment of low-back pain; the general practitioner and the chiropractor. As previously mentioned, two-thirds of patients contact their general practitioner initially and one-third contacts a chiropractor.

The scope of practice of the general practitioner when dealing with low-back pain is to make the initial diagnosis and initiate treatment and preventive measures. The general practitioner already has information regarding previous disease, hospitalisations and so forth and therefore plays a central role in the public health care system. The general practitioner is also the referral source to physiotherapists, specialists and hospital departments as well as being the individual that does any necessary follow-up work.

The scope of practice of chiropractors includes the diagnosis, treatment and prevention of biomechanical lesions in patients with back-pain.

Due to the fact that chiropractors and general practitioners represent the most commonly utilised health professions as regards ports of entry into the public health care system for the treatment of low-back pain, underscores the importance of increasing communication regarding mutual patients with low-back pain. These two health professions should formalise their communication channels so that relevant patient information can be readily retrieved by each group.

Thorough and individualised patient information regarding the diagnosis, prognosis, and treatment strategy should always be a central aspect of all patient consultations for low-back pain.

Acute low-back pain
As previously mentioned acute low-back pain is defined as pain of less than 3 months duration. Roughly 50% of patients will be free of symptoms within 3 weeks and 90% within 3 months. Ten per cent of patients will experience chronic or recurring symptoms. Most episodes of low-back pain resolve by themselves and only rarely do chronically disabling symptoms develop. Unnecessary and perhaps risky treatments can by themselves contribute to maintaining or even worsening symptoms and promoting illness behaviour.

In order to prevent unnecessary contact to the health care sec-tor, it is necessary that people are informed about the positive prog-nosis of most episodes of low-back pain. An important aspect of the future national strategy regarding the improvement of low-back pain treatment will be public information campaigns. In the future it will be important to inform the population about when it is appropriate to consult the health care system and when it is not necessary. People need to be informed about the positive prognosis most commonly associated with low-back pain whether treated or not. The information must not dramatise the issue but must also include clear guidelines as to when one should consult a health professional. The HTA-group recommends that public information include the following:

Important Public Information

Many people develop low-back pain.
Important facts to know!

Low-back pain is only rarely a result of a serious illness.

Many people with low-back pain do not need to consult a health professional.

In many cases the low-back pain will resolve within a few days.

It is a good idea to consult a general practitioner or a chiropractor if:

The pain is severe
If the pain prevents you from carrying out your daily activities for several days
If the pain does not resolve within a few days

If your are experiencing the following symptoms contact your doctor immediately!

Low-back pain accompanied with an inability to control bladder function and a lack of sensation in the groin area.
Low-back pain accompanied by decreased strength in one or both legs

In the opinion of the HTA-group, patients that consult general prac-titioners and chiropractors should be examined, observed and treated according to the guidelines presented below:

/ILLUSTRATION: The suggested course of managing acute low-back pain divided into 2 week modules/

It is important that the process including examination and treatment includes goal setting as regards treatment results and that both the health professional and the patient are conscious of these goals. Treat-ment results should be evaluated with documented assessment instruments. In Denmark the Copenhagen Back Research Association has developed an widely used evaluation journal and the Danish DiscBase employs a similar instrument. Examination and treatment results should be reported to the patient's general practitioner (conditional upon patient's agreement) in a readily understandable fashion, if the patient has been referred. If the patient wishes, this information should be sent to other health professionals. Suggestions regarding the future organisation of low-back pain assessment and treatment should be acted upon.

Chronic low-back pain
Chronic low-back pain is defined as pain lasting for more than 3 months. Chronic pain will oftentimes lead to sick-leave and many series of treatments. Patients suffering from chronic pain (depending upon the severity of the problem) are a socially threatened group. A quick and effective examination and treatment strategy must be implemented in order to avoid worsening. Most counties in Denmark do not have facilities, which can manage these cases.

The most appropriate examination and treatment program for chronic patients cannot be structured in the same rigid manner as the case is for acute low-back pain.

An individual strategy must be planned for each patient. X-rays and blood work will frequently be necessary. Generally, a good rule to follow is that the magnitude of the examination and treatment procedures should reflect the magnitude of the problem. In certain circumstances advice regarding the work place and activation regarding increased physical activity will suffice. In other cases the course should be addressed in a multi-disciplinary fashion. The latter may require several months of treatment/observation.

90% of low-back pain patients will recover spontaneously
Patients should be examined and treated in the primary sector
Treatment strategies should be planned in order to avoid unnecessary examinations, and if more than one health professional is involved, a high level of communication must be established
Continued evaluation of the course and individual information is important

7. Summary and Suggested Areas of Focus

Waiting times

Long waiting times for examination and treatment increase the risk of developing chronic symptoms. Waiting times of more than a week to consult a health professional or 2-3 weeks to consult a specialist is unwarranted. Waiting times for surgery (if indications are clear) should not exceed 2-3 weeks.

The likelihood of returning to work (with an intact work capability) decreases considerably if disabilities last for more than 1-3 months. The need of a long-term and costly rehabilitative period also increases as does the likelihood of developing associated problems such as stress, anxiety, and depression. Long waiting times also affect the prognosis of low-back pain negatively because it becomes increasingly difficult to successfully treat individuals whose status is affected by these psychosocial factors.

A good opportunity to reduce the number of patients suffering from chronic disabling low-back pain including the indirect costs due to loss of ability to work depends upon reducing waiting times for relevant examinations and treatment.

Increased inter-disciplinary co-operation

The HTA-group is of the opinion that co-operation between the different health professionals that deal with low-back pain is unsatisfactory. This has been demonstrated in DIKE's report from 1995 entitled "The Health Care System's Handling of Back Pain". According to our interpretation of the data presented in this report, a continuous theme in the answers given was the poor communication between different professionals. This is due not only to differing ways of addressing the problem but also to a lack of formalised communication between health professionals. Possible solutions to this problem have been discussed in our group. One possibility is the establishment of "wandering patient files" which go with the patient. This is already in use with obstetrics patients, a system, which results in all relevant professionals of being aware of previously undertaken diagnostic measures and treatment. Common post-graduate courses for physi-cians, chiropractors and physiotherapists should be expanded in order to promote a more uniform attitude towards low-back pain patients and furthermore that commonly utilised terms/classifications have more common ground than at present. These courses should also involve other relevant health care groups such as psychologists and relaxation therapists. The quality of post-graduate education in both the primary and secondary health care sectors could be enhanced by establishing more professorships and associate professorships.

Special courses for other participants on the low-back issue, such as social and occupational workers should be upgraded. We should strive after a situation where decisions made by these individuals are in as close agreement as possible with the latest scientific knowledge in the area.

Practice co-ordination must be evaluated and expanded so that it not only involves private practice and the hospital sector but also between health professionals and the social and communal sectors.

We suggest that a committee with representatives from all relevant health care professionals be established in order to address the issue of improving inter-professional co-operation and post-graduate education.

Individual patient information

Chronic low-back pain must be understood to be in an existential "situation" due to the fact that patients may have to learn to live with a certain degree of pain and disability. Even if the most appropriate diagnostic and treatment methods are used, it is not always possible to cure all patient symptoms. In situations such as these, work and leisure activities must be adjusted in order to maintain as high a level of "quality of life" as possible, in spite of symptoms.

It is important that patients become activated as early as possible in their treatment programs. This is most readily achieved with a thorough information phase. Patients must be made aware of their own responsibilities and must also be activated to participate in an active rehabilitation program. This is the best way to maintain their social position. It may be necessary to repeat information regarding all aspects of the strategy several times in order for patients to develop a good insight into the situation. Several health professionals with different backgrounds can be involved in the information phase. Information provided should be individualised and based upon the individual patient's situation and needs. The information phase requires 1-2 hours on the part of the health professional depending upon the magnitude of the problem.

Existing governmental supported programs such as "adult education" and "spare-time education" should also be utilised for this purpose.

It is the opinion of the HTA-group that a strengthened individualised information effort both in the primary and secondary health care sectors is an important area, which should be focused upon. Individualised patient information is so important an area that we believe that it should be perceived as an independent "service" and paid for accordingly.

Public information

Information to the general public is an area, which needs to receive more attention in the future. The population needs to be made aware of our strengths as well as our limitations as regards examination and treatment. They must be made aware that an episode of low-back pain is not dangerous and that successful treatment results depend upon their participation. If chronic pain develops our diagnostic possibilities become limited, as does the likelihood of curing the patient. This type of information must be made available to the population at large. Far too often one witnesses long-term treatment that has not resulted in a complete cure. Patients become disappointed because of unrealistic hopes and inadequate information. Public information campaigns should be planned and carried out with the help of health professionals as well as experts in communication. Additionally, they should be repeated several times in order to enhance their effect.

X-ray examination of the spine

X-rays are very often taken too early in the course of events. X-rays are also repeated within too short a time frame due to poor communication between the general practitioner, the chiropractor and the hospital. This duplication of service is unacceptable also as regards unnecessary radiation.

Formalised communication channels need to be established in order to secure that x-rays and their descriptions are always at the relevant place at the correct time. General agreement needs to be attained regarding the practical aspects of taking x-rays as well.

The only way to avoid unnecessary exposures and to increase the quality of x-rays is to develop guidelines for the taking of x-rays and to develop formalised lines of communication between heath professionals. Guidelines should be developed by the relevant professional societies as soon as possible.

Hospitalisation/amubulatory treatment/multi-disciplinary teams

Many patients are hospitalised due to low-back pain (Table 4, page ??). It has never been proven that patients benefit from hospitalisation. Hospitalisation is only indicated under certain conditions.

As previously stated, a precise diagnosis cannot always be made. Hospitalisation can result in differing and confusing information being given to the patient due to his/her coming in contact with so many different people. Additionally, patients are prone to place the entire responsibility for their conditions on the hospital staff, which may lead to increased passiveness and illness behaviour.

The great majority of acute and chronic patients can be examined without the patient being hospitalised. Preconditions for successful outpatient examinations are; that centres have multi-disciplinary teams, that only a few people are involved with a patient and that time is taken to give the patient comprehensive and individualised information.

Multi-disciplinary teams with the resources to carry out high quality outpatient examinations and treatment should be established in several areas throughout the country. Treatment of severely pained patients as well as chronically disabled patients can be carried out at these centres in order to reduce the number of patients that become hospitalised.

Quality control: databases & reference programs

The development of a systematic registration of treatment results through clinical databases has only recently begun. An example of this effort is the Danish Disc Base, which is a nation-wide registration of the clinical results obtained from disc herniation operations. This effort will be completed within 1-2 years and the information gathered from it will contribute to improving the future treatment of disc herniations. Other examples of central registration of treatment results include the database developed by the Copenhagen Back Research Association (COBRA). It is extremely important that projects such as these continue both in the primary and secondary health sec-tors and that adequate funding is made available. These databases should utilise validated outcome measurements that are comparable. This is the only way in which we can develop a picture of the overall treatment effort/results.

The registration of patient data in clinical databases should become standard procedure for every health professional. The results obtained from these databases will form the bases of reference programs. These reference programs will insure professional development based upon factual evidence.

We should insure that the development of these clinical databases is undertaken with the participation of all relevant health professional associations and that funds are provided for this work. Inter-disciplinary work groups should also be established.

Teaching/research

Many issues relating to the diagnosis and treatment of low-back pain have not been resolved. There is great need to carry out a large number of controlled trials in order to enhance our knowledge.

Formalised post-graduate education and courses should be emphasised in order to insure that patients are treated in accordance with the newest knowledge in the area. Courses, which emphasise the latest knowledge regarding the diagnosis and treatment of low-back pain patients, should be carried out by all health professional associations. Increased inter-disciplinary course activity should also be promoted actively.

We must insure that specialists in rheumatology continue to participate in the professional arena of low-back pain. The education of these specialists should not be limited to "rare" cases as has been the case in the last decade. Specialist education should be planned so that "ordinary" low-back patients are seen regularly as well.

Increased knowledge of the course of treatment

Our knowledge regarding the documentation of how specific and clear diagnoses are arrived upon as well as which treatments are most effective for specific conditions and when these treatments should be administered is lacking. We also lack information about how patients are treated presently in the public health sector as well as whether the results obtained are superior to the natural course of events. How many x-rays are taken? How many injections are given? Do these treatments help? The lack knowledge in this area has limited our HTA-group from arriving at clear recommendations involving economic issues. In the future it will be necessary to have concrete information about all of the abovementioned issues in clinical databases.

This information need not take the form of randomised clinical trials. The code words in these activities include: systematic registration, prospective observational studies, clinical databases, reference programs and economic planning. The HTA-groups suggests that, in addition to establishing data bases and increasing scientific work, the mapping out of observational data which describe what happens to the average person when patients experience a bout of low-back pain be undertaken. Is there a difference in the treatment given within the same health profession? Are there geographical differences? Does treatment help? Is the likelihood of developing chronic symptoms reduced? Why does treatment seemingly help for some people but not for others?

What are the costs involved in each treatment? The answers to these questions and others will make it possible to determine the most appropriate treatment courses and this information will form the framework for future reference programs.

The overall co-ordination of efforts/professional fee schedules

A will to confront these issues needs to be demonstrated at the highest levels. The re-distribution of resources should not end up resulting in simple money saving acts such as reducing the number of available hospital beds for low-back patients. The re-distribution of resources should instead channel resources to the areas outlined in this manuscript. This is necessary in order to effectuate a practical strategy.

The project will be made complex by the fact that so many different health professions are involved. This will entail considerable changes in the different health disciplines as well as increased co-ordination between the different groups.

Future public health fee schedules should reward the "information" phase of any treatment as an independent service. This is the most effective way to secure the needed emphasis of this important aspect of treatment.

In the opinion of the HTA-group present fee schedules reward "treatment". Increased research will document which treatment activities are useful and which ones are not. Future professional fee schedules can be determined according to scientific merit and can therefore serve as a regulatory method to enhance the quality of care provided

Reduce waiting times for relevant examination

Increase the level of information for both the individual patient and for the population at large

Develop effective channels of communication between health professionals

Establish more multi-disciplinary treatment centres

Develop databases which systematically register examination and treatment procedures

Strengthen research and education

VOLUME 2
LOW-BACK PAIN

1. The Various Danish Health Professions That Treat Patients With "Low-back pain"

Co-operation between health care providers

The treatment of low-back pain patients should to the degree that it is possible be carried out in the primary health care sector and preferably in the area where the patient lives. This will limit unnecessary illness behaviour and resource waste. Health professionals in the primary health care sector should co-operate in a close fashion for example, by exchanging journal information, x-rays and treatment results.

Treatment regimens should be the same regardless of whether a patient consults a general practitioner or a chiropractor. The information given to patients should also be the same regardless of who evaluates, informs and advises the patient.

In order to insure the fulfilment of these goals and treatment quality it is necessary to develop inter-disciplinary "low-back pain" reference programs and quality control systems in the form of nation-wide databases. These quality control instruments must become a part of daily procedures in the primary health care sector.

Patients should only be referred to the secondary health care sector in certain situations. The examination and treatment strategy design in the secondary health care sector is multi-disciplinary and should be carried out in an ambulatory fashion as far as possible. Special diagnostic examinations such as CT or MRI-scans should be carried out in close co-operation between the primary and secondary health care sectors in accordance with an overall priority plan. Results of x-rays and scanning reports should be provided in a manner such that relevant information follows the patients throughout the treatment sector. More detailed information is provided in Low-back Pain, Volume 1.

A smooth and well functioning treatment system is dependent upon all health professionals being aware of the educational back-ground and professional capabilities of all other authorised health professionals. Inter-disciplinary and inter-sector courses and professional development should be strengthened. These courses should also include representatives of the social services. There is also a great need of an increased research in both the primary and secondary health care sectors in order to among other things to record the content and results of the treatment regimens that are carried out on low-back patients in the present as well as the future.

2. The LPB-group's analytical method

HTA-blueprint

Our analyses are based upon a systematic review of material, which was made up of systematically chosen elements which when combined represent the HTA evaluation of the singularly analysed technology. The blueprint includes the following:

The Technology

The area of utilisation

What is the indication for its usage?

Is there agreement regarding the indication?

How many patients are involved?

What are the relevant alternatives?

Alternatives or supplements?

Effectiveness

What documentation is there for its effectiveness?

Is it more effective than other technologies?

Is it as effective in our population?

Risk evaluation

Are there side effects?

Are the potential side-effects reasonable compared to the potential clinical effect?

The Patient

Psychological status

Does the technology result in comfort, discomfort or anxiety?

Social effects

Are daily activities effected?

Is the ability to work effected?

Ethical aspects

Is the patient willing to accept the technology?

Is it acceptable for society?

Organisation

Structure

Should the technology be located at a few centres?

Is decentralisation possible?

Is the work distribution between hospitals and the primary health care sector altered?

Are new special functions required?

Are visitation criteria altered?

Personnel

Are work routines altered?

Will the work distribution of different health professionals change?

Will it require additional educational for health care personnel?

Are there opportunities for employment?

Environment

Will the external environment be effected negatively?

Is there a risk of a negative effect on the work environment?

Economics

Direct costs

What are the direct costs associated with the program, including: side effects, operations, nursing help at home, transportation, or medicine?

Indirect costs

What are the indirect costs associated with the program such as sick leave and loss of productivity?

Direct savings

What are the direct savings associated with the clinical effect of the program?

Indirect savings

What indirect savings will result from the implementation of the program?

We have assessed the division between the state, county, municipality, patient and others regarding all of the above mentioned savings/expenses.

The blueprint was used by the panel as a "reminder sheet". In several situations we did not use all of the individual elements of the blueprint because it would have been irrelevant.

In a few circumstances it was impossible to evaluate the technology in all aspects because we could not find the necessary information. It was impossible, for example, to determine how often every technology is used in Denmark because there is no systematic registration of this type of data.

Generally, the blueprint was a great help to the panel and it contributed to the systematic evaluation of the technologies.

The panel's evaluations

In order to assure that our evaluation process was systematic we developed a scale for the purpose of ranking each item.

Firstly, the quality of the scientific foundation for the usage of each technology was evaluated (with guidance from the international HTA-reports).

Then we estimated the expected costs for the individual technology.

Finally, the group arrived at a recommendation of either suggesting or not suggesting the usage of the individual technology.

The scientific documentation that was used by the panel

The recommendations, which follow, are based upon scientific documentation and are ranked on a four-point scale. The reader should be aware that a recommendation regarding a singular technology could either be positive or negative as regards its usage. Scientific studies can sometimes support the usage of a particular technology and in other situations recommend that they are not used.

Grading

The commentary's weight, Strength A
	Strong research based documentation, such that there are many relevant high quality studies, which support the value of a particular technology.
The commentary's weight, Strength B
	Moderate research based documentation such that there is at least one relevant high quality study or several medium quality studies, which support the usefulness of a particular technology.
The commentary's weight, Strength C
	Limited research based documentation such that there is at least one relevant medium quality study, which support the usefulness of a particular technology.
The commentary's weight, Strength D
	There is no research-based documentation, which supports the usefulness of a particular technology

Costs that are associated with the utilisation of the technology

The next process involved direct cost calculations regarding each individual technology.

Low costs
Simple treatment or exercise, which can be carried out by the patient themselves. This type of treatment can as a rule be carried out at home or at work and does not involve expensive equipment or professional help.

Moderate costs
An ambulatory treatment which is carried out at a hospital or at a health professional in private practice. This type of treatment is not very costly

High costs
A treatment that requires hospitalisation. This type of treatment is expensive.

The panel's recommendations

The LBP-group concludes each treatment evaluation with one of the following recommendations: "Recommended" / "recommended for certain conditions" / "not recommended". The numbers given are 2,1,or 0 spines

We wish to emphasise that even if a technology has received 2 spines we do not mean that it should be used in all circumstances. No treatments are relevant in all situations. That is why we have supplemented each recommendation with additional commentary. An example of this commentary would, for example, be that a particular treatment should only be used with certain diagnoses, for a limited period of time, or in combination with other treatments.

The scale, which represents our recommendations, will appear as follows:

Recommended (Symbolised with 2 spines)

Recommended for certain conditions (Symbolised with 1 spine)

Not recommended (Symbolised with 0 spines)

As previously stated, the LBP-group will, in addition to providing the evaluations of "recommended" or "recommended for certain conditions," provide explanatory commentary, so that additional clarification will be presented.

Mostly the reason for a method being "not recommended" is that there is insufficient documentation for a positive effect in relation to the resources used for the method. In other cases the treatment can not be recommended, because there is good evidence for the method being of no effect. Only in few cases have the LBP-group evaluated treatments as "not recommended" on the basis of documented evidence for direct harmful effects. In these few cases it will clearly be noted in the text, that these methods of treatment should not be used.

3. Treatment

Documented treatment effect

Ninety percent of patients will recover spontaneously within 12 weeks after experiencing a first-time episode of low-back pain. Fifty percent will recover within three weeks. The typical course of acute low-back pain results in a spontaneous recovery for 60-80% of patients irrespective of treatment. It is precisely this factor, which necessitate stringent methodological needs in the design of scientific studies in determining the clinical effect of different treatments.

There are also other methodological difficulties involved in the design of scientific studies dealing with "low-back pain".

It is difficult to arrive at a clear diagnostic classification for patients because the pathoanatomical basis for most diagnoses is questionable.

It is difficult to describe the content of the "tested" treatment because treatments are often individualised and reflect physical findings.

Studies are designed to evaluate the general effect of a treatment on a large sample population. In reality the treatment involved may be effective, indeed very effective for a sub-population of the large patient sample. This effect may not be "discovered" in the total population sample. This may be due to the type of research design, or due to the possibility that the treatment in question is not effective in the remainder of the population sample or may in fact be harmful for them.

The ideal "blinding" of the study group vs. health professional can be difficult to attain.

These factors can individually or in combination with one another result in it being difficult to carry out a reliable scientific study and make it difficult to interpret previously carried out studies.

Active or passive treatment

One of the greatest errors in the treatment of low-back pain in this century has been the unquestioned usage of passive treatments, often-times initiated when spontaneous recovery has already begun. Passive treatment runs the inherent risk of promoting passive behaviour (illness behaviour) and thereby prolonging the course of illness. This situation may lead to chronicity. Patients bear a degree of responsibility for the overuse of passive care because they have oftentimes requested or demanded it due to comforting factors. This however, does not excuse health professionals for their inappropriate choice of treatment.

Results of clinical research from the past ten years have clearly documented that pro-active treatment for both acute and chronic patients represent the most important factor for the continued effect of treatment. Patients have to be motivated to participate in active care if it is to be successful. This is most readily achieved if patients have been provided with comprehensive information regarding the diagnosis, prognosis and treatment principles.

Treatment strategies

Prior to determining the treatment strategy, it is necessary to under-take an overall evaluation of the patient's condition. How great is the problem? How high is the level of pain intensity? Can the patient manage their work? How has the condition affected the individual's ability to manage daily activities? How long has the condition been present- acute, chronic? The total treatment strategy should be planned in accordance with the answers to the previous questions. The total amount of treatment should reflect the magnitude and duration of the presenting problem.

The ordinary first-time episode of low-back pain will usually resolve within a few days and besides advice regarding general life-style and physical fitness, treatment is not usually necessary.

A patient with a chronic condition - perhaps disabling - needs a more complex treatment strategy often made up of several elements. It is important to be aware of the multi-factorial nature of low-back pain. A simple uni-dimensional treatment is rarely sufficient. The goal is therefore to design a treatment strategy that is individualised and addresses the differing areas of the problem.

Patient information

The low-back pain patient has a need of comprehensive information regarding possible pathological mechanisms as well as the diagnostic possibilities or the lack thereof. Furthermore, the frequently benign nature of most episodes of low-back pain should be underscored. The chosen treatment strategy should also be discussed thoroughly. Prior to beginning treatment patients should be made aware of goals regarding pain relief, improved functional levels, work and so forth. The duration of treatment as well as eventual risks should also be reviewed.

Treatment strategies for chronic pain patients necessitate the active involvement of both the health professional and the patient as well as co-operation between them. It is important to inform the patient that there are no miracle cures and that success is dependent upon sincere participation on the part of the patient. A conversation with the patient regarding these central principles of illness and treat-ment cannot be completed in less that 20 minutes. It is often important to carry out another information session 2-4 weeks into treatment in order to repeat the most important aspects of the treatment strategy.

The following statements include the most important facts about "low-back pain" - as we know them.

It is not usually dangerous to experience low-back pain and work will only rarely worsen the condition.
It is almost always best to continue going to work even of there is pain present.
Long-term sick-leave will not improve the condition - on the contrary, the risk of never returning to work only increases.

The HTA-evaluated treatments

The most commonly used treatments for low-back pain will be addressed. We begin with the treatments that can be recommended and follow with those that cannot be recommended. Treatments are listed in alphabetical order within each category.

4. Treatments Which Can Generally Be Recommended

TREATMENT METHOD

Manual therapy

Technology
Manual therapy can be broadly defined as all procedures where the health professional uses his/her hands in order to influence a joint complex as well as the surrounding tissues. Treatment is given in order to relieve pain and improve function.

The procedures include manipulation and mobilisation, but also related techniques such as manual traction, myofascial release, and muscle energy techniques. With manipulation a motion segment of the spine is pushed beyond its normal passive range of movement by means of a thrust.

This treatment is often combined with other methods such as soft tissue treatment and medication in the case of acute pain or exercise in the case of chronic pain.

Contraindications
There are a series of factors, which contraindicate manual treatment in certain conditions. Conditions in which the symptoms are a result of cancer, inflammation, infection, or when the patient is suffering from serious and/or progressive nerve root irritation are examples of this. In situations where the low-back pain is determined to be of functional origin but where structural weakness of the bones or joints as seen for example with severe degeneration, osteoporosis or joint displacement, treatment should be appropriately modified.

Documentation

It is not possible to predict which individuals will benefit from
manual treatment (B).

In addition to pain treatment indication is supported by the clinical observation of functional disturbances of the motion segments of the low-back or the joints of the pelvis (D).

Manual treatment has been investigated in a multitude of clinical studies and there is evidence that acute low-back pain episodes can be shortened with manual treatment (B).

There is evidence that manual treatment has a short-term effect on chronic low-back pain, but the literature is inconclusive about long-term benefits. At present there is no evidence of the utility of continued manual treatment (B).

There is limited evidence of a positive treatment effect with patients suffering from nerve root irritation (C).

Risk evaluation
Manual treatment is generally a very safe treatment when relevant contraindications are addressed. Approximately 25% of patients experience short-lived tenderness in the treated area. Serious complications are considered to be rare. The development of cauda equina syndrome (nerve root pressure with bladder function impairment) has been described.

Costs
Moderate costs
Treatment is primarily administrated in the primary health care sector and is ambulatory

Recommendations
Recommended
Manual treatment can be recommended for patients suffering from acute low-back symptoms and functional limitations of more than 2-3 days duration.

Recommended
Manual treatment can be recommended as an initial treatment for acute exacerbations of recurrent or chronic low-back pain and functional limitation .

Recommended for certain conditions
Manual treatment can be considered as an element of a broader strategy for chronic low-back trouble.

Recommended for certain conditions
Manual treatment can be considered as an element of a conservative
treatment regime in patients suffering from nerve root irritation taking into account the previously mentioned contraindications.

TREATMENT METHOD

Back school/group training/ergonomics

Technology
The term "back school" implies providing information about the anatomy and function of the spine as well as advice on activities regarding prevention and self-treatment. Teaching is carried out in group sessions. It is common to include instruction and practical guidance for exercise during back school sessions. The total duration of the back school is approximately 4-6 hours. Oftentimes the theoretical instruction is an integrated element of a comprehensive course of back rehabilitation, which also includes exercise programs. The integrated rehabilitation program is usually of 15-30 hours duration, spread over weeks to months. Back school programs are usually led by physiotherapists, ergotherapists and relaxation therapists.

The traditional back school has been evaluated in several randomised trials. The philosophy was guided by "be careful" messages, such as; sit correctly, lift correctly, avoid forward bending, and so forth. In a modern back school the emphasis is to avoid fear, and the philosophy is to "ignore the pain as much as possible". This change in attitude has resulted in improved preventive results

Documentation

There are several scientific studies, which have not demonstrated any short or long-term effects from the "traditional back school" with low-back pain patients (B).
A "modern back school" where teaching has focused upon "ignoring the pain as much as possible" has demonstrated a preventive effect with patients suffering from low-back pain (B).
Back school should include physical activity and promote attitudes which work against the development of chronic disabilities rather than "be careful messages" (B).
Several scientific studies assessing prevention at the workplace have shown a reduction in sick leave due to low-back pain (B).
Patients with a well-defined need of rehabilitation such as post-operative disc herniation patients demonstrate a reduced likelihood of developing chronic symptoms after participating in back school/rehabilitation programs (C).
As regards lifting technique: Objects should be lifted while "bending at the knees" as opposed to bending the spine forwards if the weight is more than 10-12 kilograms. Relatively few lifts of light objects during the course of a days work will in all likelihood not increase the risk of injuring the spine and therefore do not require special precautions. However, repeated lifting during the day - light or heavy objects - necessitates specific ergonomic instruction (D).
As regards the ergonomics of sitting: Uncomfortable furniture should obviously be exchanged in order to achieve a more comfortable sitting posture. It is important that individuals have the opportunity to "test" different types of furniture prior to purchase because factors reflecting sitting comfort and table height may be individual (C).
Other areas of ergonomics not relating to sitting and lifting, such as the psychological environment of the workplace, have not been thoroughly investigated in a scientific manner and recommendations must therefore be guarded (D).

Costs
Moderate costs
Ambulatory treatment.

High costs
Purchase of teaching aides/ergonomic materials. (From low costs to high costs depending upon the type of course).

Recommendations
Recommended
Both the modern back school and group training can be recommended for patients with low-back trouble if there is a clear need of rehabilitation, or when preventive efforts are being considered at work places where work tasks can be challenging for the low-back.

Recommended for certain conditions
Individual ergonomic instruction - such as advice regarding sitting comfort and lifting conditions can be considered especially if repetitive lifting can be reduced.

TREATMENT METHOD

Pain relieving medication

Technology
Pain relieving medication is sold "over the counter" (without pre-scription) (for example paracetamol) or with a prescription if a higher dosage is required such as NSAID (non-steroid anti-inflammatory medication = pain relieving arthritic tablets).

Stronger pain relieving medication such as morphine derivatives can also be utilised.

Documentation

Several studies have documented the effect of paracetamol, NSAID and stronger analgesics for the relief of acute low-back pain (B). It has not been determined whether paracetamol or NSAID is more effective (C).
There are no studies, which document an enhanced clinical effect of morphine derivatives compared to either paracetamol or NSAID (C).
There are no studies, which document any long-term effect of pain relieving medication for chronic low-back pain (C).
There are no studies which document that utilising several medications at the same time results in additional benefit (C), however, the risk of side-effects generally increases with the utilisation of several drugs (B).
Several studies have shown that a singular medication may result in a varying effect upon differing individuals (B).
There is a risk of both physical and psychological dependence when using morphine derivatives after as short a time as a few weeks (B).

Costs
Low costs

Recommendation
Recommended
Evaluate if there is in fact a need of pain relieving medication. If there is use a stepladder approach. Increase the dosage after 1-2 days if there is a lack of effect from the initial medication.

First step

Paracetamol up to full dosage
If there is a lack of effect, go to the next level:
NSAID up to full dosage
If there is a lack of effect, go to the next level:
A combination of paracetamol and NSAID
If there is a lack of effect, go to the next level:
Tramadol or codeine in conjunction or as a monotherapy (evaluate individually). There may be CAVE obstipation from codeine

Individual considerations must be taken into account when using paracetamol and NSAID. Patients rarely experience benefit of pain relieving medication for more than a month or so (1-3 months).

Stronger medication (morphine derivative) should only be prescribed for relatively short periods of time (max. 1-2 weeks). These medications should only be used in periods of severe acute pain, after surgery, or if the abovementioned principles have been ineffective.

If patients have sleeping difficulties, sleeping pills in addition to pain relieving medication can be used for a short period of time.

Muscle relaxants such as Diazepam have no place in the treatment of low-back pain. The possible clinical benefit is overshadowed by the risk of physical and psychological dependency even after short periods of usage.

TREATMENT METHOD

Exercise therapy according to McKenzie

Technology as a form of treatment
The background for this exercise program is that movements in the low-back can either increase or decrease patient symptoms. The therapist can guide patients as they repeat certain movements until they find the movement which either reduces symptoms or centralizes them (distal pain moves centrally toward the vertebral column). Programs are designed according to the "preferred" movements and patients are instructed to carry out their individual programs up to several times per day.

There are several studies, which have investigated the McKenzie method, but most of them are methodologically weak.

There is little risk of side effects for patients, and an advantage of these exercises is that patients assume responsibility for carrying out their treatment and are therefore activated.

Documentation

There are a few studies, which show a positive clinical effect with patients suffering from acute low-back pain (with or without radiating symptoms) (C).

A few studies indicate a positive clinical effect with patients suffering from chronic low-back pain (with or without radiating symptoms) (C).

Costs
Low costs
Home treatment.

Moderate costs
Ambulatory treatment.

Recommendation
Recommended for certain conditions
McKenzie exercises can be considered as a treatment method for both acute and chronic low-back pain.

The McKenzie Technology as a diagnostic method
When patients repeat a specific movement the preferred type of movement can be determined. This is therefore a useful diagnostic instrument for low-back patients in which the pain source is one or more discs in the low-back.

Documentation

Several studies indicate that the method has value as both a diagnostic tool and a prognostic indicator (+/- discogenic pain) (B).

Costs
Moderate costs
Home treatment.

Recommendation
Recommended
This technique can be recommended as a diagnostic method for both acute and chronic pain syndromes.

TREATMENT METHOD

Exercise therapy/fitness

Technology
The therapy consists of a series of specific movements with the goal of increasing muscle strength, improving joint movement and body co-ordination by carrying out a systematic training program. The expectation is that the exercise therapy/fitness will improve movement restrictions, improve functional levels and reduce pain. Exercise therapy/fitness can be particularly effective in increasing tolerance for physical activity and illness behaviour in chronic low-back pain patients.

Documentation for the usage of the technology with acute low-back pain patients

There is no evidence that specific exercises introduced in the acute phase of low-back pain will shorten the duration of the episode. Patients that are encouraged to remain as active as possible during the acute phase seem to do better that those patients performing a series of specific exercises. There are only a few studies in the literature which deal with this issue (C).
It is important that patients maintain or improve their physical condition through training after the acute pain has resolved (B).

Documentation for the usage of the technology with sub-acute low-back pain patients (from 6 weeks to 3 months)

There are studies, which indicate that back exercises of certain intensity - according to therapeutic instruction- should begin after 6 weeks of continued low-back pain and reduced mobility (B).

Documentation for the usage of the technology with chronic low-back pain patients

Several studies document that a high dosage exercise (twice a week for a period of 2-3 months) is an effective treatment for chronic low-back pain (B).
Patients with chronic low-back pain who have psychological problems and are at risk for losing their contact to the work force can in certain situations have additional benefit from a combination of training/ergonomic instruction/psychological intervention (D).

Costs
Low costs
Home exercises.

Moderate costs
Ambulatory treatment.

Recommendations
Recommended
The treatment can be recommended for patients suffering from low-back pain for 6 weeks or more.

Recommended for certain conditions
Can be considered as a preventive effort for patients who have experienced several episodes of low-back pain.

5. Treatment Methods That Can Be Recommended In Certain Conditions

TREATMENT METHOD

Injections in the muscles, joints, and ligaments and in close approximation to nerves, including acupuncture

Technology
The term injections is meant to include the injection of liquid or acupuncture needling -dry needling- in soft tissues for example in "trigger points" = special pain centers (muscles), ligaments, fascia, bursae, in joints, near nerve tissue for example in a joint cavity, or an epidural injection in the spinal canal.

Injection treatment can be carried out in order to provide relief or as a diagnostic measure. Relief of pain may provide evidence that the site of injection was in fact the source of pain.

Treatment can involve/use any of the following:

Dry needling/acupuncture

Hypertonic salt water

Anaesthesia (local anaesthetic)

Steroids

NSAID

Phenol

Combinations of b, c, or d.

The most common combination is an anaesthetic + steroid usually in a combined volume of 5-10 ml.

Usually a single injection is performed but there may be a need of 1-2 repetitions during the course of a month. The total number of injections should not exceed 3. The time interval between injections is dependent upon the liquid injected as well as the volume. Acupunc-ture can be performed by unauthorised health workers provided that it is done under medical supervision.

Side-effects
Occasionally (less than 1 out of 10,000) a serious complication can take place in the form of a local infection around the area of the injection. The risk of infection depends upon the content of the injection.

Repeated injections with steroids involve a risk of serious systematic side effects.

Injection with phenol is not recommended due to the fact that permanent damage to the skin and connective tissue in the area of injection may take place.

Repeated injections increase the risk of passivity and illness behaviour on the part of the patient and we therefore recommend extreme caution. Due to this we advise that injection treatment be combined with patient activating strategies.

TREATMENT METHOD

Injections in trigger points, muscles and ligaments

Documentation

There is limited and non-conclusive research based documentation regarding the diagnostic or clinical value of injections for acute low-back pain (C).
There is limited research based documentation for either the diagnostic value or short-term clinical effect with chronic low-back pain and no documentation of long-term effects (C).

Costs
Moderate costs

Recommendation
Recommended for certain conditions

Facet joint injections cannot be recommended as a treatment but they may be considered as a diagnostic procedure in certain situations.

TREATMENT METHOD

Facet and sacroiliac joint injections

Documentation

There is only limited scientific evidence of any clinical effect regarding acute or chronic low-back trouble (C).
There is no documentation of any clinical effect of injecting the sacroiliac joints, but there is some documentation for the utility of this method as a diagnostic tool (C).

Costs
High costs

The treatment is carried out in an ambulatory manner at hospitals with imaging guidance.

Recommendation
Recommended for certain conditions

Facet joint injections cannot be recommended as a treatment but they may be considered as a diagnostic procedure in certain situations.

TREATMENT METHOD

Epidural injections

Dokumentation

There is limited research based evidence that steroid injections with or without local anaesthetic have a pain relieving effect for weeks/months with acute low-back pain patients with radicular symptoms (C).
There is no evidence of any clinical effect with acute low-back patients without radiating symptoms or with chronic low-back pain patients (D).

There is evidence of a risk of rare but serious complications from injections (A).

Costs
High costs

Recommendation
Not recommended

TREATMENT METHOD

Acupuncture

Documentation

There is a limited amount of research based evidence for a short-term pain relieving effect with acute or chronic low-back pain patients but no evidence of any long-term effect (C).

Costs
Moderate costs

Recommendation
Not recommended

We do not recommend that acupuncture be used for low-back pain patients because the possible clinical benefits do not outweigh the costs and eventual risks.

TREATMENT METHOD

Massage and heat/cold therapy

Technology
Soft tissue treatment, which increases blood circulation or decreases tension.

Documentation:

There are a few studies, which demonstrate a short-term pain relieving effect but no long-term effects (B).

Costs
Low costs
Home treatment.

Moderate costs
Ambulatory treatment.

Recommendation
Recommended for certain conditions
We do not recommend this treatment generally but it can be considered for pain relief for localised muscle pain or for initial pain relief/relaxation prior to using other documented treatment methods such as manipulation, exercise therapy and so forth.

TREATMENT METHOD

Back surgery

The technology
There are several different operative methods as well as operation types for differing conditions in the back. In the text that follows operation types are grouped into three main categories. This report will not deal with all of the different operative methods involved for example in treating fractures or different anomalies of the spine such as scoliosis:

Operation or re-operation for a disc herniation.
Operation for spinal stenosis (narrowing of the spinal canal).
Operation for spinal instability.

There can of course be situations where a combination of the above mentioned procedures or indeed all of them may be involved. Operations are rarely performed purely on the basis of low-back pain but more often due to low-back pain with radiations to the leg or legs. Dominant leg pain will more frequently result in surgical intervention than low-back pain alone. There is a lack of prospective controlled clinical trials for all of the procedures mentioned.

Both neurosurgeons and orthopaedic surgeons perform the above mentioned operations. Local and regional organisational fac-tors determine which medical departments perform the different procedures described. The important developments in spinal surgery necessitate that both of the medical specialities involved need to co-ordinate their activities to a greater degree so that patient selection and chosen operative techniques in all regions are conducted according to a common consensus.

The total number of surgeries (A, B, & C) performed in Denmark number approximately 4,000 per year.

Disc herniation
The technique used for performing first-time or repeat surgery for disc herniations is well known and requires low-tech equipment. The procedure is carried out by means of a partial laminectomy (hemilaminectomy). A small amount of bone tissue is removed and the exposed nuclear and disc tissue is removed. A repeat surgery is essentially the same procedure but more bone tissue is removed prior to removing scar tissue.

Indication
First-time surgeries are not usually performed before conservative therapy has been attempted for 4-6 weeks. In addition there has to be a positive correlation between clinical findings and imaging reports. Subacute operations may be performed if a patient is experiencing progressive weakness in the leg during the course of a few days or if the pain is extremely severe in spite of medication.

Acute operations (within hours or days) are carried out if there are signs of cauda equina syndrome.

Commentary
Three thousand operations of this type are performed per year. In the counties that have departments of neurosurgery operations are primarily carried out at these departments. However, these procedures are also carried out at orthopaedic departments particularly in counties in which there are no neurosurgery departments.

In addition to the described operation technique other tech-niques such as microsurgery (involving a microscope) may be used. This type of surgery has not demonstrated shorter post-operative hospitalisation stays. It seems as though microsurgery results in a greater number of relapses.

Documentation:

There are many relevant but uncontrolled studies, which demonstrated a long-term effect on pain after surgery. Only a single ran-domised study compared the results of operations to conservative care (C).
Success rates are in the range of 70-90%. The risk of serious complications is rare (A).

Costs
High costs

Recommendation
Recommended
Surgery can be recommended provided that the above mentioned criteria are present.

TREATMENT METHOD

Spinal stenosis

Procedures for spinal stenosis involve well-known and low-tech instrumentation. This procedure involves a more comprehensive removal of bone tissue and nerve decompression than disc herniation procedures.

The diagnosis is made with MR-scans or with functional myelography eventually supplemented with CT-scans.

Indications
There must be a clear correlation between long-term functional disturbances, objective clinical findings and imaging results before considering this procedure.

Commentary
These operations are carried out at either neurosurgery or orthopaedic departments. Approximately 300 are performed per year.

Dokumentation

There is scientific documentation as regards pain relief in 60-70% of patients when the previously mentioned criteria are present (B).
Symptom relief of more than a few years has not been proven but benefits can be difficult to demonstrate due to the progressive nature of degenerative processes (D).

Costs
High costs

Recommendation
Recommended for certain conditions
This procedure can be recommended in certain instances if the previously mentioned criteria are present.

TREATMENT METHOD

Stabilising back surgeries

Stabilising back surgeries require more operation equipment, specialised tools, metal for fixation, and bone transplant material (preferably from the patient or from a bone bank). This procedure is therefore both a low and a high-tech procedure. This operation (3-8 hours) is much more invasive that the previous procedures. Particularly long lasting operations may require blood transfusions. This type of operation results in more complications than the previously discussed procedures and complications may be of a very serious nature.

Twenty to forty per cent of patients require additional surgeries because of a lack of healing of the bones.

Indications
The surgical candidate must undergo a comprehensive examination program possibly involving a test period during which he/she wears a corset. This may help in determining whether a "stiffening" operation will be helpful. The radiological examination procedures are also considerable. In addition to plain x-rays one or several of the following examinations may be involved; MR-scan, myelography and CT-scan.

In order to determine whether there is a clear indication for surgery there has to be a clear correlation between the history, the symptoms, the objective examination and the imaging results.

Commentary
Five to six hundred patients undergo this procedure each year. Pain may be due to instability or painful movement. Patients will often- times have undergone operations for disc herniations or spinal stenosis.

This type of operation should be performed in a few centres only and in close co-operation between neurosurgeons, orthopaedic surgeons and rheumatologists. The uncomplicated cases can be operated on in smaller centres in co-operation with major centres.

Documentation

There is no clear scientific documentation for pain relief or functional gains. There is empirical evidence that states that 50-70% of all patients experience benefit if the previously mentioned criteria are present (D).

Costs
High costs

Recommendation
Recommended for certain conditions
This procedure can only be recommended in particularly well chosen cases in which the patient has clear surgical indications.

Commentary
Work is going on to define more certain operation indications and prognostic factors.

Costs can run up to 80-100.000 DKK per operation. This procedure is still in a developmental stage and more controlled studies need to be carried out.

TREATMENT METHOD

Bed rest

The technology
In cases where there is a suspicion of disc herniation bed rest (23-24 hours per day) is carried out in order to unburden the back.

Documentation

There is evidence that even a few days of bed rest for patients where there is no suspicion of disc herniation increases functional loss and enhances the likelihood of chronic symptom development (B).
There is empirical evidence that patients who are suspected of suffering from disc herniations will benefit from bed rest of up to one week's duration. This benefit can result in long-term pain relief for some patients (D).

Costs
Low costs
Home treatment.

High costs
Hospitalisation.

Recommendation
Not recommended
Bed rest for patients not under suspicion for disc herniation should be discouraged. If patients are suffering from severe pain, bed rest can be considered as a pain relieving measure for a maximum of 1-2 days.

TREATMENT METHOD

Transcutaneous nerve stimulation

The technology

There are several studies dealing with this treatment but results are unclear. Some studies demonstrate an apparent pain reduction in patients suffering from chronic symptoms (B).

Costs
Low costs
Home treatment.

Recommendation
Recommended for certain conditions
We do not recommend this treatment as a commonly used procedure. It can be considered in certain patients suffering from chronic pain.

6. Treatments That Cannot Be Recommended

TREATMENT METHOD

Corsets

The technology
Specially sown material corsets or soft material belts.

Documentation:

A positive clinical effect has never been demonstrated and there is little scientific data (D).

Costs
Low costs

Recommendation
Not recommended
Cannot be recommended.

TREATMENT METHOD

Traction

The technology
This treatment is carried out with an apparatus, which stretches the back as well as the paraspinal structures.

Documentation

There are approximately 20 studies of good scientific merit. These studies do not indicate a clear clinical effect of traction with either acute or chronic patients with or without sciatica (A).

Costs
Moderate costs
Ambulatory treatment.

High costs
Hospitalisation.

Recommendation
Not recommended
We do not recommend this treatment for low-back pain with or without sciatica. There is a risk of symptom exacerbation in rare circumstances

TREATMENT METHOD

Ultra sound, laser, short-wave therapy

The Technology
Soft tissue treatment with ultra sound/laser/short-wave therapy.

Documentation
Several studies have been carried out. There is no documented clinical effect (A).

Costs
Moderate costs

Recommendation
Not recommended
These therapies cannot be recommended.

7. Prevention

The most important elements in the design of effective preventive efforts have already been mentioned in this report. This chapter will therefore summarise the most important areas that should be focused on.

The scientific evidence regarding proven prophylactic interventions is not strong. The literature on prevention is sparse. In addition, social and cultural factors in different societies will greatly effect the manner in which the individual patient as well as society at large will perceive concrete prophylactic projects. This makes it difficult to determine how prophylactic measures in one society will work in another.

As the case has been for international consensus reports dealing with the area of prevention/prophylaxis our group has been unable to find sufficient data to undertake an HTA-evaluation of the individual measures. Due to the same reasoning we will not grade the individual intervention's strength.

Prevention can be divided into two different "areas of effort" which are defined according to the group, which is the focus of the intervention.

Primary prophylaxis is defined as interventions for people who have no low-back symptoms either at the present time or in the past and who have no identifiable risk factors. Examples of primary pro-phylaxis include ergonomic changes at home or at work, advice regarding physical activities, information campaigns to the general public about how to react to an episode of acute low-back pain and so forth.

Secondary/tertiary prophylaxis refers to interventions for individuals who have already suffered from low-back pain. The effort is primarily aimed at preventing a reoccurrence of symptoms (secondary prophylaxis), or reducing the effects of poor health or reducing the social costs of already existing low-back pain so that chronic disabilities are prevented (tertiary prophylaxis).

Primary prevention

Primary prophylaxis is often seen in public information campaigns, in which the public at large is warned about improper behaviour. These campaigns have rarely shown their effectiveness. A short-term information campaign has no long-term effect on the health attitudes/behaviour of the general public. Only back school carried out at work places (page 66) has demonstrated a preventive effect as regards sick-leave due to low-back pain .

Ergonomic interventions have only demonstrated a marginal effect in several scientific studies. A reduction in the frequency of heavy and repetitive lifting and the elimination of inappropriate work stations (page 66) can have a certain effect on the frequency of future episodes of low-back pain. When workers feel "comfortable" it is doubtful that further ergonomic intervention will result in any meaningful gains. It is therefore most important to weigh any possible intervention with possible benefits.

It is therefore important to regard most "general" ergonomic initiatives as being geared to improve the job satisfaction rates of workers rather than an effort to actually reduce sick leave due to low-back pain. In other words: Ergonomic improvements can have a great effect on the comfort levels or workers without reducing sick leave.

We recommend that future primary prophylactic initiatives focus upon the avoidance of clearly inappropriate work situations such as the elimination of very heavy or repetitive lifting, or sudden unexpected movements which can stress the back. This may reduce the number of accidents and other work-related injuries.

Other ergonomic projects such as the changing of all non-ad- justable writing desks to desks which can be adjusted in height have a primary goal of improving comfort as opposed to reducing the number of work related injuries and accidents. The economic priorities related to differing prophylactic interventions should be based upon realistic expectations as regards possible meaningful results.

We must be aware of the fact that information campaigns with slogans such as: "4 hours of physical activity a week", or "10 minutes of exercise at every break", or "an hour a week at a fitness centre" and so on have not demonstrated any short or long term effect. Experience tells us that individuals who are not ill are not motivated to participate in preventive activities. There is also the risk of a counter productive effect from messages of this sort. It is important that the central messages of information campaigns are not moralising. Information should be presented in a neutral fashion such as explanatory information about the function of the back, examination techniques and available treatments. Advice about how future patients should tackle their first episode of low-back pain would also be helpful. This type of message does not demand something of the individual in the immediate future such as doing something that will promote health but rather increases the publics level of knowledge about the low-back issue. Informed individuals will possible react more rationally if they encounter a future episode of low-back pain.

Secondary/tertiary prophylaxis

One of the most important goals of this type of prophylaxis is to prevent an ordinary acute episode of low-back pain from developing into a chronic and disabling low-back condition. Many risk factors can contribute to the development of chronic pain in the 10-15% of people with acute low-back pain that develop chronic symptoms. Particular factors such as long-term sick-listing, psychological stress or depression, and poor job satisfaction play important roles. See Low-back Pain vol. 1 pages 26-28.

In the future it is important that the average course of treatment addresses these known risk factors in order to decrease the likelihood of chronic pain development. In order to reduce illness behaviour double treatment should be avoided. It is also important to reduce waiting times for examinations and treatments. Patients risk developing chronic symptoms while simply waiting for further treatment or examinations. We refer to Low-back Pain vol. 1 page 43. Lastly, we must make sure that patients are provided with thorough information about their condition, treatment, prognosis, and prevention so that uncertainties and anxiety levels are reduced.

An important area which should be focused upon is providing special rehabilitation programs for patients who have experienced long-term low-back pain or serious disabilities regarding the ability to manage daily activities, so that functional capacities can become normalised or at least as good as they can be. Studies show that rehabilitation programs for patients who have undergone disc surgery insure that a larger number of patients return to a normal level daily functioning at their jobs and at home than if a rehabilitation program is not completed.

Further research is still necessary in order to identify the most important secondary/tertiary efforts where the effect of the intervention is greatest related to associated costs.

Social assistance programs

An area, which requires additional focus, is the co-operation between health professionals, the social sector and the work place.

The opportunity to return to work in a flexible manner such as short or long-term "protected jobs" is important in order to secure that individuals suffering from severe acute pain can maintain their jobs.

The rehabilitation of injured workers should also be co-ordinated by the abovementioned sectors.

It is important that all relevant social services are utilised when needed by individual patients. They include:

Sick-listing.
An agreement in which sick leave support is paid from the first day (§28).
Declarations suggesting that workload be lessened.
Work tests.
The design of work places and tools.
Wage support during periods of re-schooling.
Assessing workers capabilities.
Flex jobs.
Protected jobs.

Additionally, we refer to the Service Law of July 1, 1998.

"The sick-listing of patients should as far as possible be done by-general practitioners in order to secure that he/she retains their primary role in the co-ordination of continued treatment."

Every individual county should take the initiative to develop and maintain close co-operation between all professionals involved. In order to secure that all relevant social services are provided to individual patients, it is necessary to have procedures clearly delineated.

The previously mentioned secondary/tertiary prophylactic measures may appear to be rather obvious. However, they are not carried out in reality because the health care sector cannot offer the necessary rehabilitation and work hardening programs due to a lack or co-ordination between the different players and due to a lack of resources.

8. Economics

We mentioned several of the difficulties in calculating the total costs to society of low-back pain in "Low-back Pain, Vol. 1". There is a lack of clarity about the total treatments provided in both the primary and secondary health care sectors. Different methods of calculation result in different conclusions. Lastly, it is difficult to calculate many of the individual services. How much does it cost to carry out a x-ray examination. Should one include the costs of maintaining a x-ray unit or building costs? What about heating the premises? It is difficult to separate singular costs out of the total costs of running a department because many different activities take place in the same area by the same personnel.

We calculated in "Low-back Pain, Vol.1" that the total yearly costs related to low-back pain was approximately 10 billion Danish Dkk of which 3 billion DKK were direct costs and the remainder indirect costs.

Costs of the singular activity

It is easier to calculate treatment costs than total costs to society. In the Appendix we have attempted to clarify the costs associated with different treatments for the individual patient that are typically offered in the health care sector. In order to simplify the problem costs are based upon a typical 4-week examination and treatment course in which a particular examination and treatment activity is carried out. We point out whom it is that pays for treatment; the commune, the state or the patient.

Note that we have chosen typical and common examination and treatment courses but one can easily imagine many other equally typical courses.

The reader should be warned against comparing the cost of one type of service with another and thereupon concluding that funds can be saved if we always utilise the least expensive service. For example, 4 weeks of pain relieving medication treatment is much cheaper than a 4-week course of treatment at a physiotherapist or a chiropractor. Treatment types are rarely comparable. The content of treatments differs, as do patient needs.

Calculations should primarily serve to provide us with an overview of the costs associated with an individual course of treatment and which extra costs can be incurred if inappropriate treatment is begun.

Box economic analysis of a course of treatment for "low-back pain"

The table below contains a so-called box-economical analysis. In other words a view of which boxes finance the given examples of health services for patients with back pain. Treatment at a relaxation therapist is not subsidised by the public health care system and payment is therefore made by the patient alone. On the other hand a consultation at a general practitioner or a specialist is fully paid for by the public health care system. Medication is partially subsidised. Patients receive compensation (in the table we have used 50%). As regards support for privately practising physiotherapists and chiropractors support from the public health care system is 40% and 30% respec-tively. Hospital treatment is completely paid for by the county.

Pay during sick leave is paid for by the employer, public employers, and the commune. Private employers pay for the first 2 weeks of sick leave while the remaining sick leave period is paid for by the commune in which the individual resides. Public employers pay for the entire sick leave period. Employers who continue to pay full wages under sick-leave are entitled to receive the support that the commune would have paid to the employee during the sick-leave period. The state refunds 75% of the costs incurred by the commune for sick-leave wages.

Examples of treatment courses and the division of boxes of typical services in DKK

Cost categories County Municipality The state Patient In total

Public
health
insurance Hospital
sector

General practitioner *) 396 0 0 0 0 396

Physiotherapist in private practice **) 576 0 0 0 864 1.440

Chiropractor in private practice **) 221 0 0 0 1.104 1.325

Medical specialist **) 907 0 0 0 0 907

Medicin - inexpenive 28 0 0 0 28 56

Medicin - expensive 98 0 0 0 98 196

Relaxation therapist 0 0 ****) 0 1.200 1.200

Hospital treatment 0 24.246 0 0 0 24.246

2 weeks of hospitalisation for a disc herniation operation 0 17.964 0 0 0 17.964

Ambulatory treatment 0 7.141 0 0 0 7.141

Payment of sick-leave benefits***)

Sick-leave benefits *****) 0 0 672 2.016 0 2.688

*) From the Department of Health Insurance, Århus County.

**) The office of the Department of Health Insurance. 1998, Schultz law service. Health laws. Schultz Information.

***) On the precondition that sick-leave benefits are paid entirely by the commune whereupon the state refunds 75% of the costs.

****) Some communes subsidise treatment costs.

*****) Per week.

Savings if "recommended treatment courses" are carried out

In order to arrive at the possible economic savings attainable if we strive to carry out desired treatment courses, the LBP-group has constructed 2 typical treatment courses. We have calculated the direct costs as well as the costs associated with sick-leave benefits.

For an example we have chosen treatment of an acute low-back disc herniation. In both of the "constructed" cases conservative treatment has failed and surgery has followed. We preclude that surgery has been successful and that the patient returns to work in good health. The examples are typical of long-term treatment courses. Upwards of 10,000 patients per year are treated for acute low-back disc herniations for shorter or longer periods of time. Conservative treatment is successful in the majority of patients but surgery is necessary for 25-30% of patients. Patients are typically sick-listed for 4-12 months in conjunction with treatment for disc herniations. As described in Low-back Pain, Vol. 1 many acute episodes of low-back pain (including those without disc herniations) lead to long-term sick-listing, much treatment and the occasional hospitalisation. We assume that many more than the 10,000 disc herniation patients go through similar courses of treatment as we described. The exact number is impossible to present.

The recommended course
Patients receive treatment in the primary health care sector. Only the necessary health professionals are involved and there is good communication between them and no unnecessary waiting time. A physiotherapist or chiropractor carries out the treatment in association with the patient's general practitioner. As there is no effect from the administered treatment the patient is referred to the spine center of the hospital. There is no effect of the hospital treatment but treatment is carried out without wasting time. This is followed by a CT-scan, surgery and rehabilitation (also without undue waiting time).

The non-recommended course
The patient is examined and treated by several health professionals in the primary health care sector. There is insufficient communication between the health professionals and unnecessary waiting times develop. Due to a lack of improvement the patient is hospitalised on two different occasions for further examination and treatment. The first hospitalisation was of 2 weeks duration during which conservative treatment was attempted without clinical results, and a CT-scan was ordered. There is considerable waiting time both for the CT-scan as well as for surgery. At present, waiting times for a CT-scan are approximately 3 months as are waiting times for surgery. In this example, rehabilitation will be necessary for a longer period of time than in the desired course of treatment due to the fact that the physical state of the patient is relatively worse after surgery and the many months of waiting.

The Figure, which follows, illustrates the two different treatment courses plotted against a time axis. The recommended course ends with a discharge after 20 weeks while the non-recommended treatment course ends with a discharge after 44 weeks.

/ILLUSTRATION: Figure. Treatment for disc herniation/

Costs

As we can see from the following calculation the "undesired treatment course" is more than twice as expensive to carry out as the "desired treatment course". Patients in the "desired treatment course" in all likelihood experience a greater degree of patient satisfaction. There is a greater chance of achieving a complete cure and maintaining work capabilities for these patients as well. However, our calculations only relate to economic costs.

Costs associated with the "desired treatment course" (in DKK):

General practitioner 384.-

Physiotherapist/Chiropractor (average) 1.390,-

Back center 7.141,-

Hospitalisation and operation 17.964,-

Rehabilitation (alternative 1) 2.000,-

Inexpensive + expensive medication 1.008,-

Sick-leave benefits *) 53.760,-

In total 83.647,-

Costs associated with the "undesired treatment course" (in DKK):

General practitioner 384,-

Physiotherapist 1.440,-

Chiropractor 1.325,-

Medical specialist 907,-

First hospitalisation 24.246,-

Hospitalisation and operation 17.964,-

Rehabilitation (alternative 1) 2.000.-

Inexpensive + expensive medication 2.772.-

Sick-leave benefits *) 118.272.-

In total 169.310.-

*) In an economic analysis one should also include production loss in conjunction with sick-leave. Due to the uncertainties associated with loss of productivity we have included the costs associated with sick-leave benefits instead.

One should also include the costs associated with disability pensions for patients, who have not been helped by treatment and must leave the work force. Patients, who receive the middle level of pension, are paid 9,097 DKK per month, which results in a yearly cost of 110,000 DKK. Should an individual receive a disability pension for the rest of his/her life this will result in a considerable amount of money.

The implementation of improved and more effective treatment courses will in addition to saving money in the health care system also reduce costs related to sick-leave benefits and disability pensions.

How can these savings be achieved

It is important to underscore that the desired treatment course can enhance the likelihood of achieving satisfactory treatment results thus decreasing the likelihood of chronic symptom development in addition to considerable savings.

The amount of savings is particularly dependent upon our ability to succeed in the following:

To avoid "expensive" waiting times
To achieve the best possible communication between the involved health professionals and the relevant social authorities.
To avoid unnecessary and meaningless examinations and treatments