J Alternative and Complementary Med 2008 (Jun); 14 (5): 465473
Adam Wilkey, Michael Gregory, David Byfield, Peter W. McCarthy
Private Practice, Oldham, United Kingdom
OBJECTIVE: To compare outcomes in perception of pain and disability for a group of patients suffering with chronic low-back pain (CLBP) when managed in a hospital by either a regional pain clinic or a chiropractor. DESIGN: The study was a pragmatic, randomized, controlled trial.
SETTING: The trial was performed at a National Health Service (NHS) hospital outpatient clinic (pain clinic) in the United Kingdom.
SUBJECTS AND INTERVENTIONS: Patients with CLBP (i.e., symptom duration of >12 weeks) referred to a regional pain clinic (outpatient hospital clinic) were assessed and randomized to either chiropractic or pain-clinic management for a period of 8 weeks. The study was pragmatic, allowing for normal treatment protocols to be used. Treatment was administered in an NHS hospital setting.
OUTCOME MEASURES: The Roland-Morris Disability Questionnaire (RMDQ) and Numerical Rating Scale were used to assess changes in perceived disability and pain. Mean values at weeks 0, 2, 4, 6, and 8 were calculated. The mean differences between week 0 and week 8 were compared across the two treatment groups using Student's t-tests. Ninety-five percent (95%) confidence intervals (CIs) for the differences between groups were calculated.
RESULTS: Randomization placed 12 patients in the pain clinic and 18 in the chiropractic group, of which 11 and 16, respectively, completed the trial. At 8 weeks, the mean improvement in RMDQ was 5.5 points greater for the chiropractic group (decrease in disability by 5.9) than for the pain-clinic group (0.36) (95% CI 2.0 points to 9.0 points; p = 0.004). Reduction in mean pain intensity at week 8 was 1.8 points greater for the chiropractic group than for the pain-clinic group (p = 0.023).
CONCLUSIONS: This study suggests that chiropractic management administered in an NHS setting may be effective for reducing levels of disability and perceived pain during the period of treatment for a subpopulation of patients with CLBP.
From the FULL TEXT Article:
It has been accepted that most patients suffering acute lowback
pain (LBP) recover rapidly, with 90% expected to be pain free after a few weeks.  However, to suggest that LBP is self-limiting and that early symptom reduction constitutes resolution appears to be an oversimplification, with the general course accepted as being recurrent.  A high
percentage of patients, 3575%, may experience pain for up
to 4 weeks,  and significant numbers, 10%75%, may remain symptomatic after 1 year. [4, 5, 8, 1618] Within these groups, patients suffering recurrent episodes of pain with the duration of symptoms unspecified may also be included.
The proportion of the population reported to be suffering
with persistent or chronic low back pain (CLBP) varies
from 8% to 33%. [79, 13] Of these, up to 13% accounts for a stable core of patients whose symptoms are persistent, with the remaining patients fluctuating in and out of chronic episodes. [7, 9, 10]
Treatment that is available for patients suffering with CLBP appears almost inexhaustible, although the evidence for the effectiveness of many of these therapies is questionable [10, 1620] and as such, national guidelines that have been produced vary widely with regard to the timing and type of interventions that are advised. [3, 10, 21]
Within the National Health Service (NHS), the terminal
referral point for those suffering with CLBP is often the local
pain clinics.  National guidelines do not suggest at what point this referral should occur, with vast regional differences present throughout the United Kingdom and focus of the pain clinic primarily being placed upon symptom relief.  To the authors knowledge, no trials have assessed the effectiveness of NHS pain clinic protocols in the management of CLBP, although most of the treatment modalities utilized have been studied. [10, 1720, 24] This signifies the gaps in delivery of care for patients with chronic pain.
Much has been written about manipulation in the treatment
of LBP, and while it has been accepted over the past decade as a treatment for acute LBP, [2, 10, 2528] its effectiveness in the treatment of CLBP remains under scrutiny. [10,16,21]
Meade and colleagues  reported that chiropractic manipulation was found to be effective in the treatment of certain subgroups of patients suffering with LBP. Although this study was not faultless in design, with potential bias due to treatment location, [29, 30] it was shown that the benefits
gained by patients receiving chiropractic treatment were prolonged. 
In anticipation of such a criticism, the current study was
performed in an NHS setting. The aim of the study was to
compare the effects of management additional to that given
by a General Practitioner (GP), either under the direction of
a regional pain clinic or chiropractic management for a
group of patients suffering with CLBP. The patients included
in this trial were monitored for 4 weeks prior to and
during the treatment period only.
Two consultant anesthetists from the Royal Oldham Hospital, Lancashire, and one chiropractor, who had been in private practice for 15 years, were used for the screening, selection, and treatment of all participants within the trial.
Selection of patients
All patients within the trial were selected from NHS referrals to the Pain Clinic at The Royal Oldham Hospital, Oldham, Lancashire, UK. The requirements for inclusion were LBP for at least 12 weeks with or without radiation into the legs and that they were between the ages of 18 and 65 years. Patients were excluded from participating if they were found to be suffering with any one or number of the following: neurologic disease, neurologic deficit
arising from prolapsed intervertebral disc, spinal stenosis;
acute fracture; history of spinal surgery; history of carcinoma; and gross anatomical abnormality. In addition, those patients who had high comorbidity resulting in significant disability from other disease states were also excluded.
Following initial screening, all patients were assessed by
physical examination and interviewed by the same clinician
(chiropractor). Outcome measures were administered at this
point. If there was any question regarding the exclusion criteria, then agreement to include the patient was obtained
from all of the authors, otherwise the patient was excluded
from the study. Imaging studies, normally x-ray films, were
performed if there had been no history of imaging within
the previous 2 years. All imaging was performed by the
hospital radiology department and reported on by hospital
radiologists. Information sheets were given to those patients
who met the criteria. These patients were advised that they
had the choice of whether or not to participate. Patients
were contacted after 7 days and those who wished to be included were randomized into the treatment or control group
by way of sealed envelope (20 envelopes for each group):
This consisted of randomly mixed, sealed envelopes being
chosen and opened by one of the hospital secretaries who
then contacted the patient, advising them of their allocation. The process of allocation was performed independently of the treating clinicians. A baseline period of 4 weeks was used following screening before treatment commenced, when outcome measures were again administered to ensure that levels of pain and disability had remained consistent.
Control group subjects followed normal treatment protocols established within the pain clinic at the discretion of
the treating consultant.  There were no restrictions placed upon the resources that were available to them, provided that treatment fell within their accepted protocols. The treatment regimens employed by the pain clinic in this study consisted of standard pharmaceutical therapy (nonsteroidal anti-inflammatory drugs, analgesics, and gabapentin), facet joint injection, and soft-tissue injection. Transcutaneous electrical nerve stimulation (TENS) machines were also employed. These modalities were used in isolation or in combination with any of the other treatments.
Chiropractic group subjects followed an equally unrestricted and normal clinical treatment regimens for the treatment of CLBP were followed. All techniques that were employed are recognized within the chiropractic profession as methods used for the treatment of LBP. Many of the methods used are common to other manual therapy professions.  Side posture diversified manipulation to the lumbar spine and pelvis,  flexion distraction,  and lumbar and pelvic drop techniques  provided the articular manipulation. Trigger points as described by Travell and Simons  were treated using stretching techniques, ischemic compression, [35, 36] dry needling,  and Post-isometric Relaxation stretching.  Soft
tissue massage and other resistance stretching techniques
were also utilized  to help reduce chronic muscle shortening. Home exercises were prescribed, and advice regarding posture and activities of daily living were given where appropriate. The frequency of treatment was at the discretion of the chiropractor.
The treatment period was 8 weeks with a maximum of 16 treatment sessions for each patient. Treatment outcome questionnaires were completed by the patients at screening, initial treatment, and thereafter at 2-week intervals during the treatment period. For those patients not attending a clinic regularly during the 8-week treatment period, the questionnaires were posted with a self-addressed envelope. Patients who did not return mailed questionnaires were telephoned and reminded.
All treatment, control, and experimental groups received
their treatment within the hospital pain clinic setting at The
Royal Oldham Hospital. Approval to perform this trial was
sought and granted via the West Pennine NHS Trust.
Treatment outcome questionnaires
An 11-point (010) numerical rating scale (NRS) was used
to measure subjective pain intensity. Two scales were employed, one measuring current pain and the second average
pain over the preceding 2 weeks. Disability was measured with
the Roland Morris disability questionnaire (RMDQ). Both of
these tools have been used extensively within the research literature for measuring self-perceived pain and disability. [12, 37, 38] A medication diary was used to determine whether there was a change in the frequency of medication used per week. Additionally, an 11-point patient satisfaction questionnaire was completed following the 8-week treatment period.
For both outcome measures, the mean values at weeks 0, 2, 4, 6, and 8 were calculated. Following discussions with an independent clinical statistician and applying tests for normality of distribution of the data (skewness and kurtosis), it was decided that it was appropriate to apply parametric statistical analysis. The mean differences between week 0 and week 8 in both perceived pain and disability were compared across the two treatment groups using Students t-tests. 95% confidence intervals (CI) for the differences between groups were calculated. Analysis was performed using SPSS version 14.0 (SPSS Inc., Chicago, IL).
We did not intend to enter into detailed analysis of intracontrol group variables related to treatment protocols in this
study. The sample size was based on previous studies and
was appropriate to the level of analysis performed, based on
an level of 0.05.
Forty-eight (48) patients attended for an initial screening.
Ten (10) were excluded: 4 due to findings of neurologic involvement in their symptoms, 2 because of high co-morbidity, 1 with pain attributable to trauma to the coccyx, 1 was
pain free, 1 was too old at the time of screening, and 1 was
found to have a degenerative hip as the most likely cause of
their symptoms. Of the remaining 38 patients, 8 (4 male and
4 female) declined the offer of being included in the trial (no
reasons being given or requested for their decisions). A total of 30 patients were included within the trial. The method
of randomization chosen (40 sealed envelopes, 20 for each
group) led to 12 patients being randomized to the pain clinic
and 18 to the chiropractic group. The basic demographics for
both groups can be seen in Table 1. There was a loss of a
further patient in the control group as a result of serious illness and 2 patients from the chiropractic group; of the latter, 1 declined to give a reason and the other failed to return phone messages or respond to letters that were sent. A total of 27 patients completed the course of treatment.
The mean duration of symptoms within the chiropractic
group, 7.34 years (0.520 years), was almost twice that of
those assigned to the pain clinic, 4.04 years (0.510 years).
While the duration of symptoms differed between the groups
(Table 1), the peak duration was similar: 3 years for the pain
clinic group and 2.5 years for the chiropractic groups, respectively. The mean age for those within the chiropractic
group was higher than that of the pain clinic: 48.5 (range
3161) years compared to 39 (range 2664) years.
Figures 1 and 2 show the data ranges collected for both
RMDQ scores and pain intensity scores (NRS) for the pain
clinic and chiropractic groups from the baseline values to 8
At 8 weeks, the improvement in RMDQ for the chiropractic group was 5.52 points higher than for the pain clinic group (95% CI 1.99 points to 9.03 points; p 0.004: Figure 3). Improvement in pain intensity at week 8 was 1.79 points
higher for the chiropractic group than for the pain clinic
group (95% CI 0.257 points to 3.22 points; p 0.023: Figure
4). See Table 2 for further details.
The mean attendance for treatment in the pain clinic group was 1.9 sessions compared with 11.3 for the chiropractic group. Three (3) patients within the control group were seen only once with treatment administered at the initial consultation with the follow-up falling outside of the 8-week treatment period and only 2 patients within the same group were seen on three occasions over the 8 weeks.
The primary aim of the study was to assess the effectiveness of chiropractic treatment compared to that administered by a regional pain clinic for CLBP with regard to disability and symptoms. This was to be performed within a secondary care setting to reduce the possibility of bias within the treatment groups,  although there may have been a possibility that an expectation bias may have been introduced, with patients expecting treatment solely from the pain clinic. The remit of the pain clinic is left very open as described earlier in this text, and a recent study argues against the likelihood of such bias being introduced. 
The nature of the clinic was such that none of the patients included had previously received chiropractic treatment. This fortunately reduced the chance of bias being introduced in either a positive or negative way from experiences or expectations that
a patient may have encountered as a result of previous treatment experience. Both groups showed an apparent reduction in disability scores over the treatment period, as demonstrated by the scores using the RMDQ (Table 2). Using an
NRS for perceived pain, the pain clinic group apparently
showed a slight but nonsignificant increase in mean scores
compared to a significant reduction in mean scores within
the chiropractic group (Table 2, Figure 4).
As a preliminary study, the numbers used within the trial are small, with 27 completing the treatment. The results, however, still revealed that chiropractic treatment produced highly significant improvements (p 0.004) in disability scores in this cohort compared with the treatment administered by the pain clinic during the period of treatment. A difference of 2.5 on the RMDQ is regarded by many to be clinically important.  Jordan et al.  suggest that for improvement to be clinically important, there should be a 30% reduction in RMDQ from the baseline value and that this should be in combination
with improvements on a global rating scale. The results of the current study reveal a mean reduction of 5.9 points on the RMDQ for chiropractic patients, suggesting that both statistical significance and clinically important improvement was achieved. Significant improvements were also found in perceived pain levels (p 0.023) in the chiropractic group, although in both instances the 95% CIs were wide possibly, resulting from the small number of participants. It would therefore be advisable for a future study to include larger numbers within trials to ensure that the results are robust, can be replicated, and are not due to statistical anomaly.
In the past, treatment comparisons between chiropractic
management and hospital outpatient care for LBP have been
based on treatment being administered in different locations
(i.e., within NHS and private locations ), resulting in criticism because of the potential for bias.  However, this has recently been disputed. It was decided in this instance to remove the potential for any suggestions of such bias by providing all treatment within an NHS pain clinic setting. All patients included were secondary or tertiary referrals from within the NHS system to the pain clinic, either directly from GP or orthopedic department referral, thereby reducing again any potential bias gained by patients receiving treatment of their choice.  One similar study  compared chiropractic manipulation to medication and acupuncture in a hospital setting, again showing positive results for the manipulative group. However, this was a trial studying chronic
spinal pain and was not limited to LBP, was more restrictive in treatment protocols (i.e., purely restricted to manipulation in one of the groups), and was performed in Australia where the health care system varies from that within the UK, suggesting that caution must be exercised when comparisons are drawn.
Other criticisms that may be leveled at the methods and results achieved within the current study also need to be addressed. The number of treatment visits for the chiropractic group is higher than the number of treatments received by the pain clinic group, and therefore an argument may be forwarded that the benefits gained may be in part due to the greater doctorpatient contact. [42, 43] That said, it was possible for the control group to be seen more regularly than they were. While this is a study comparing two differing treatment regimens, it may also serve to highlight some of the
possible strengths and weaknesses of the systems in which
the regimens work. All of the facilities available to the pain
clinic under normal circumstances were also available within the trial, and therefore treatment could include, among others, acupuncture and physiotherapy. During this trial, patients within the control group received pharmaceutical, TENS, or injection therapy.
It has been found that generally chiropractic patients have
a higher number of treatment visits than those who visit medical practitioners, which may give the impression that costs are greater, but ultimately it has been shown that overall costs were less for chiropractic care than for medical care. [44, 45] However, in these studies surgical intervention was included within the medical costs. In the current study for chronic mechanical LBP, surgery is not usually indicated, with medical focus based upon pain management within the remit of the local pain clinic. Cost effectiveness does play an important role when considering which therapies are most beneficial, and a careful investigation and summary of the
costs involved in both forms of treatment studied would be
Meade et al.  have shown that the benefits received from chiropractic treatment are prolonged; however, their trial was not limited to patients suffering with CLBP, and it may be that the longevity of the treatment effect was found to be more prevalent in certain subgroups. As a preliminary study, the current study was limited to a treatment period of 8 weeks without follow-up investigation. This produces obvious limitations regarding conclusions that can be reached in terms of longevity of any apparent improvement. Although a follow-up period would reveal whether the benefits gained through chiropractic therapy are maintained in patients suffering with CLBP, this would have required a much larger
initial cohort size in order to have sufficient patients complete the trial for the appropriate statistical analysis.
Extensive research has been carried out over the past 25 years in an attempt to discover the most effective methods for treating LBP, in many cases testing monotherapies or individual aspects of treatment regimes. [2, 3, 10] Current theories and evidence suggest that multidisciplinary methods of treatment are most beneficial.  It has become apparent over the
years that no one method of treatment is going to be effective for each individual suffering with CLBP. [16, 41] Even within the multidisciplinary setting there will be differences in response. There are also cost implications in organizing and running multidisciplinary centers, and while utilizing local resources that are already established may have some benefit in reducing such costs, more work is required to establish which treatment regimens are most effective in the various subgroups of patients.
This preliminary study suggests that chiropractic management can be administered in an NHS setting and appears to
offer some benefit to patients suffering with CLBP with an
apparent biomechanical component. The benefit consists of
reduction of both perceived pain and disability, at least during the period of treatment. Further work is needed to determine whether these effects extend beyond the period of treatment. These results would appear to suggest that chiropractic
management within an NHS setting should be a cost-effective option for treatment for patients suffering with CLBP.
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