CCA- Canadian Chiropractic Association - 11Chapter

Clinical Guidelines for Chiropractic Practice in Canada

Chapter 11 - Outcome Assessment

Chapter Outline

I.Overview
II.Definitions
III.List of Subtopics
IV.Literature Review
V.Assessment Criteria
VI.Recommendations (Guidelines)
VII.Comments, Summary or Conclusions
VIII.References
IX.Minority Opinions

I OVERVIEW

The goal of this chapter is to develop a generic summary of typical chiropractic procedures, and a rating thereof. Most chiropractic named technique procedures consist of a combination of various analytic and treatment components. These have been broken down into the ACA Council on Technique approach (Bartol) and treatment components have been given ratings based on the literature and expert opinion.

Chiropractic practice employs a wide variety of specific adjustive and manipulative techniques. While there is a sound body of scientific evidence on the efficacy of chiropractic spinal manipulation for various conditions, there is a paucity of literature on the comparative effectiveness of specific chiropractic techniques. In these circumstances recommendations or guidelines have been developed by combining a critical evaluation of the literature that exists with a consensus of expert opinion from field practitioners. There needs to be more research on specific chiropractic techniques and, as new information arises, the guidelines in this chapter will need continuous review.

  • Consistently evaluate the effect of care over time
  • Help indicate the point of maximum therapeutic improvement
  • Uncover problems related to care such as noncompliance
  • Document improvement to the patient, doctor, and third parties
  • Suggest modifications of the goals of treatment if necessary
  • Quantify the clinical experience of the doctor
  • Justify the type, dose and duration of care
  • Help provide a data-base for research
  • Assist in establishing standards of treatment for specific conditions.

    This chapter will recommend methods of assessing outcomes of chiropractic care based on defined criteria, scientific evidence, and expert opinion that are valid, reliable, clinically useful in chiropractic practice, and able to be interpreted by those interested in the role of chiropractic health care in society.

    Traditionally, in subjective areas such as symptoms of pain and ability to perform daily activities of living, clinicians have relied on the informal self-report of patients. In recent years other methods of patient report, based on questionnaires or survey instruments of proven validity and reliability, have converted patient reports from 'soft' evidence to 'hard' evidence which may be at least as valid as objective outcome assessments performed by a health professional. This is an important development for chiropractic practice given the nature of complaints commonly presented by patients.

    II DEFINITIONS

    For definitions see the Glossary at the end of this publication.

    Analysis
    Anecdotal Evidence
    Assessment
    - Disease (Condition specific) Assessments
    - General Health Assessments
    Case Control Study
    Chiropractic Care
    Descriptive Study
    Diagnosis
    Inter-Rate Reliability
    Instrument
    Meta-Analysis
    Practicality
    Outcome Measure
    Randomized Controlled Trial (RCT)
    Reliability
    Responsiveness
    Safety
    Sensitivity
    Spinal Manipulative Therapy (SMT)
    Subluxation Complex
    Validity

    III. LIST OF SUB-TOPICS

    A. Functional Outcome Assessments
    B. Patient Perception Outcomes
    i. Pain Indices
    ii. Patient Satisfaction
    C. General Health Assessments
    D. Physiological Outcomes
    i. Range of Motion (regional)
    ii. Thermography
    iii. Muscle Function

      a. Muscle Function Assessed Using Automated Means
      b. Muscle Function Assessed Using Manual Methods
    iv. Postural Evaluations
    v. Apparent Leg Length Inequality
    E. Subluxation Syndrome
    i. Vertebral Position Assessed Radiographically
    ii. Abnormal Segmental Motion Assessed Radiographically
    iii. Abnormal Segmental Motion Assessed by Palpation
    iv. Soft Tissue Compliance and Tenderness
    v. Asymmetric or Hypertonic Muscle
    vi. Reflex Testing
    F. Principles of Application

    IV LITERATURE REVIEW AND DISCUSSION

    The literature on outcome assessments can be divided into studies that have devised their own procedures, those that have tested the validity of the procedures, and those studies which have used the procedures in assessing the outcome of some type of treatment (McDowell & Newell 1987, Aday 1989). Types of outcome measures useful in health care include functional outcome assessments, patient perception outcomes, general health assessments, variations in pain indices before and after treatment, physiological outcome assessments and the assessment of the components of the chiropractic subluxation complex (Deyo 1991, Bombardier 1987).

    A. Functional Outcome Assessments

    In this chapter the term 'functional outcome assessments' (FOAs) refers to questionnaires which measure a patient's limitations in performing the usual activities of daily living. These are of particular value in cases, such as those of patients with low-back pain, where it is difficult to ascertain the exact diagnosis. FOAs assess the effects of a disorder and the outcome of care directly rather than inferring them from physiological tests.

    A large number of FOAs are described in the scientific literature. Most have been developed to assess the behavioral effects of disorders of the musculoskeletal system and to assess the effects of the treatment of those disorders. Reading (1980) and Deyo (1990) outlined many of the functional tests used in back pain research. Some of the tests include:

  • The Pain Disability Index (Tait 1987)
  • The Million Disability Questionnaire (Million 1982)
  • The Oswestry Disability Questionnaire (Fairbank 1980)
  • The Roland Morris Disability Questionnaire (Roland 1983)
  • The Waddell Disability Index (Waddell 1982),
  • The Dallas Pain Questionnaire (Lawlis 1989).

    Vernon and Mior (1991) have developed a modification of the Oswestry Questionnaire for measuring neck disability.

    A detailed discussion of the validity, reliability, responsiveness, relevance, feasibility, and safety of many of the functional scales is beyond the scope of this chapter. Further information can be obtained from the book Measuring Health: A Guide to Rating Scales and Questionnaires (McDowell and Newell 1987). Streiner and Norman (1989) provide an easy to read analysis of the development of health measurement scales.

    There are at least thirty randomized clinical trials of spinal manipulative therapy (SMT) for painful complaints in the scientific literature (Shekelle 1992, Haldeman 1991, Ottenbacher, 1985, Anderson et al. 1992). In one meta-analysis (Anderson et al. 1992), the authors categorized the outcome assessments in 23 randomized trials into eight categories: patient report of pain, overall clinical improvement assessed by the patient, overall clinical improvement assessed by the doctor, range of trunk flexion, range of trunk extension, straight-leg raising, work activities, and activities of daily living (ADL).

    In general, the outcomes showing the greatest improvement with treatment by spinal manipulation were the functional measures (activities of daily living) and patient reports of pain. Outcome assessments in the form of ranges of trunk motion did not indicate as much improvement on the average, although improvement was certainly demonstrated in a proportion of studies. Clinical trials using the straight-leg raising test as an indicator of improvement demonstrated mixed results, which is not surprising given the very mixed nature of the patients' complaints.

    Most clinical trial investigators created their own functional scales and so did not use standardized outcome assessments of known validity and reliability. Berquist-Ullman (1977) used patients reports of pain and dysfunction. Rasmussen (1978) used a measure of pain, spinal mobility, function and "fitness for work." Coxhead et al. (1981) reported measures of patient report of pain and return to work. Ongley et al. (1987) reported disability scores, and visual analog scales. MacDonald et al. (1990) used a disability scale, and a linear analog pain scale. Nevertheless, most trials demonstrated a responsiveness to treatment.

    Hadler et al. (1987) used the standard Roland Morris Disability Scale. Meade et al. (1990) used the Oswestry Disability Questionnaire. Hsieh (1991) concluded that the Roland Morris Questionnaire and the Oswestry Questionnaire gave consistent but slightly different results in a chiropractic clinical trial.

    A recent study analyzed changes in the score of the Oswestry Pain Disability Questionnaire and in the results of straight-leg raising and lumbar flexion. Chiropractic treatment was shown to be more effective than hospital outpatient management, for patients with chronic or severe back pain (Meade et al. 1990).

    Clinicians contemplating the use of functional instruments should be aware of differences between them and be able to choose the most appropriate assessment for their specific situation.

    B. Patient Perception Outcomes

    Patient perceptions of pain and satisfaction have not traditionally been considered very important as outcomes in any quantitative fashion. This is probably because it was felt that patient perceptions were too subjective and variable to be much use. This is despite the fact that clinical impressions of the value of treatments are most likely based on favourable comments by patients to their practitioners. Currently, however, health services researchers have discovered that patient perceptions, measured with appropriate procedures, may be an excellent way to measure many aspects of the quality of care (Donabedian 1980, Cherkin 1990).

    This section will consider two types of instruments of measurement of patient perception-pain indices and patient satisfaction.

    i) Pain Indices:

    Most patients who consult chiropractors are experiencing neuromusculoskeletal pain. Approximately two-thirds of chiropractic patients present with pain in the low-back, neck or extremities and approximately 10% with headaches (Shekelle and Brooke 1991, Nyiendo 1989, Kelner et al. 1980, Vear 1973). Accordingly, measure of changes in pain perception by patients before and after treatment is an important outcome assessment in chiropractic practice.

    In the acute stage, pain is a symptom indicating that tissue damage has occurred. In the chronic state, pain may persist in the absence of detectable tissue trauma. Chiropractors such as Sandoz (1985) and Vernon (1990) have recognized the importance of utilizing pain measure techniques as a means of evaluating the success of their care. Recently, a great deal of research on pain measurement has become available in the general scientific literature (McDowell & Newell 1987, Melzack, 1983).

    Pain has a number of dimensions including severity (intensity), duration, and frequency. The dimension that is most commonly assessed is severity (Jensen 1986). Methods run the gamut from single questions to complex surveys. In most cases, patients report their own perception of pain.

    Visual Analogue Scales (VAS) consist of a 10 cm line anchored by 2 pain descriptors at either end of the line. Patients are asked to mark the line at a point that represents their perceived pain intensity. The properties of VAS have been extensively studied (Huskisson 1982). Numerical Rating Scales (NBS) ask the patient to choose a number between 0 and 100 that represents their pain intensity. Another pain scale uses eleven ranked levels numbered 0 to 11 graphically depicted in boxes (Streiner & Norman 1989).

    A comparison among the types of scales commonly used indicated there were few differences between them, except that the VAS and the NRS were more practical (Jensen 1986).

    Pain diaries can be useful to measure other dimensions of pain. Patients are instructed to indicate daily on a form the intensity, duration and frequency of their pain complaints. Parker (1978) used a patient report headache diary recording severity, duration and frequency, and a disability score calculated from it. Pain diaries may also be very useful for single-case time-series research designs (Keating, 1985).

    The Borg Pain Scale is a commonly utilized visual analogue scale during the initial and subsequent progress examinations. When used appropriately it may be reflective of changes in pain and may provide an outcome measure of the prescribed treatment (Huskisson, 1982).

    The McGill Pain Questionnaire (Melzack, 1975) was designed to provide a quantitative profile of three psychological dimensions of pain. These dimensions are sensory-discriminative, motivational-affective and cognitive-evaluative. The questionnaire has been used in back pain treatment research and to describe chiropractic patients (Nyiendo, 1990). The McGill Questionnaire consists of twenty categories of words that describe qualities of pain. Patients indicate which words apply in their cases. At least six different pain variables can be calculated from the instrument. While relatively well-studied in terms of validity and reliability (McDowell & Newell 1987), the McGill Pain Questionnaire may present some practical difficulties in clinical practice because it should be administered by an interviewer.

    Most if not all clinical trials of SMT have utilized some methods of measuring pain. For example, Coyer and Curwin (1955) used an outcome of "well" defined by lack of signs and symptoms of low-back pain presumably judged by the doctor in consultation with the patient.

    Edwards (1969) assessed treatment on a 5 point scale of signs and symptoms judged by the doctor. Glover et al. (1974) used a scale of pain relief from 0 to 100%, Doran and Newell (1975) used a patient reported 6 level pain relief scale. Koes et al. (1992) reported a randomized clinical trial for back and neck pain using severity of complaints and "global perceived effect," a subjective assessment of overall improvement.

    Lopes et al. (1991) in another clinical trial, for cervical pain, assessed pain and range of motion comparing a single manipulation to a mobilization. Both favourably affected range of motion, but manipulation was more effective in reducing the pain measures.

    ii) Patient Satisfaction:

    Patient satisfaction is an important perception having not only to do with the actual effectiveness of treatment, but also the setting and the process of receiving care (Donabedian, 1980). Patient satisfaction may be an important marker of quality of care (Cleary, 1988), and it is increasingly evident that patient satisfaction is a consumer marketing target for managed care organizations. For the great majority of ambulatory patients, certain dimensions of satisfaction may be assessed regardless of the nature of the health complaint or the diagnosis.

    A satisfaction scale designed specifically for patients with low-back pain (Deyo 1986) has recently been validated addressing three key dimensions of satisfaction: caring, information, and effectiveness (Cherkin in press).

    Patient satisfaction outcomes vary not only with the presenting complaint but also with the severity of the condition and thus patient expectations. Ware (1978) and Lochman (1983) have identified a number of aspects of patient satisfaction that can be measured. These include: interpersonal manner, technical quality, staff communication skills, location/convenience, professional skills, efficacy/outcomes, finances, and availability. The Patient Satisfaction Questionnaire measures eight indices (Ware 1983). Ware also developed four questions which measure patient satisfaction with care. According to Cherkin (1990), the Visit Specific Satisfaction Questionnaire (Ware, 1988) is appropriate for chiropractic outcomes.

    C. General Health Outcome Assessments

    Assessment of general health status is philosophically congruent with the chiropractic viewpoint; that is, an emphasis on health as opposed to disease. General health has been notoriously difficult to define in operational terms, but progress in recent years has led to the development of a number of useful instruments that are increasingly being used in order to assess the outcome of health care (Nelson 1989, Bronfort 1991). A full detailed discussion of health status measurement is beyond the present scope, but an excellent review of the difficult conceptual issues and examples of various scales can be found in a book edited by Spilker entitled, Quality of Life Assessments in Clinical Trials (1990). See reference Kirschner (1987) also.

    The Sickness Impact Profile (SIP) (Berger 1981) is an extensively studied patient survey of a number of behavioral and psychosocial dimensions thought to reflect general health status: sleep and rest, eating, work, home management, recreation and pastimes, ambulation, mobility, body care and movement, social interaction, alertness behaviour, emotional behaviour, and communication. It has been used in back pain research (Deyo 1986) as well as in other areas.

    Another measure of general health was developed during the Medical Outcomes Study (Stewart, 1988) and has now been modified by Interstudy (1990). This is the SF36 questionnaire, which measures three major health attributes (functional status, well-being, and overall evaluation of health) and eight health concepts which yield eight indices: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, energy/fatigue, pain, and general health perception (Interstudy, 1990). The SF36 appears to be a useful way to standardize assessments across many types of clinical settings and for a variety of types of patients. The SF36 has been used in several chiropractic outcome studies (Nyiendo 1991, Kassak 1991, Jose 1991).

    Another useful general health measure is the set of COOP Charts (Nelson 1987). These utilize simple representative pictures as choices to answers that yield nine indices of general health. Three focus on specific dimensions of function, two are related to symptoms or feelings, three are concerned with perceptions, and one is a health co-variant. They appear to be very practical, easy to administer and score and correlate well with other less practical measures.

    D. Physiological Outcome Assessments

    Several types of evaluation fall under the general heading of physiological outcome assessments. These include range of motion tests for the trunk and peripheral joints, thermography, muscle function testing by hand and with instruments, and the assessment of posture and relative short leg.

    i) Range of Motion (regional):

    A standard examination of spinal and other joint physiology includes the measurement of the range of motion (ROM). ROM is used to assess disability and impairment because of the assumed relationship to spinal function (AMA 1988). Lack of motion is a treatable dysfunction that can be addressed by a variety of manual and rehabilitative procedures. Commonly these are manual therapy, electrotherapy and exercise therapy. Regional trunk and neck mobility along with peripheral joint mobility will be considered in this section. Segmental spinal joint mobility is addressed in the section on subluxation syndrome.

    Instruments used in measuring ROM vary considerably both in cost and in responsiveness. These range from standard joint goniometers and flexible gauges to inclinometers with magnetic yokes for cervical rotation and more sophisticated tools, many with electronic data recording capabilities. Mobility can be assessed with the patient actively involved, or as the passive object being mobilized. One or all planes of motion may be assessed. Some movements, such as trunk rotations, are less reliable than others (Liebenson 1989).

    The reliability of a number of common methods of measuring the mobility of the lumbar spine was reviewed by Liebenson (1989). He concluded that the modified Schober Technique, inclinometers, flexible rulers, and spondylometers had received the most scientific support.

    The fingertip-to-floor method was not considered valid because of errors introduced by hip motion, hamstring flexibility and arm length. Zachman (1989) compared the simple goniometer and the "rangiometer" and assessed examiner reliability for cervical ROMs. The "rangiometer" was considered moderately reliable. Nansel (1989) concluded that taking the mean of five repeated measures of cervical lateral flexion with an inclinometer was also a reliable method.

    Correlation of objective measures of trunk motion and muscle function with low-back disability rating was studied by Triano and Schultz (1987). They identified myoelectric activity, trunk strength ratios and ranges of trunk motion as objective indicators of low-back pain disability. The Oswestry Low-Back Pain Disability Questionnaire score was found to be significantly correlated with the presence or absence of relaxation in back muscles during flexion.

    While most studies of SMT have concentrated on lumbar spinal mobility, a number of trials assessed motion in the cervical spine. Brodin (1982) measured neck pain and cervical mobility as outcomes. Nordemar (1981) and Mealy (1986) used neck pain and cervical mobility. Howe (1983) assessed measures of cervical mobility, and improvement in pain and stiffness. Lopes (1991) also assessed range of motion and pain immediately after manipulation.

    The reliability of kinematic measurements of the range of regional spine motion (neck or trunk mobility) has been repeatedly demonstrated in clinical trials of manipulative therapy (Anderson in press, Ottenbacher 1985), and under laboratory conditions. Nansel et al. (1989) measured cervical lateral bending asymmetries with a simple goniometer and found the asymmetries could be reduced by lower cervical adjustments. In an additional study, rotational asymmetries in the transverse plane were reduced by upper cervical adjustments (Nansel 1991).

    Evans (1978) reported outcomes of spinal flexion, while Sims-Williams (1978, 1979) used spinal mobility (goniometer), and straight-leg raising. Zylbergold (1981) made use of assessments of spinal mobility, and Nwuga (1982) used measures of spinal mobility and straight leg raising. Farrell (1982) used a functional rating questionnaire and lumbar motions as outcomes. Godfrey et al. (1984) utilized spinal mobility, while Gibson (1985) measured spinal flexion.

    Arkuszewski (1986) used six signs and symptoms on a 3 point scale: posture, gait, pain, active spinal mobility, manual examination of spine, and a neurological evaluation.

    Waagen (1986) used a global index of spinal mobility created by summing the results of all planes of motion. Mathews (1987) also measured spinal mobility. Hoehler (1981) used measures of spinal mobility, straight leg raising, activities of daily living, and patient report of effectiveness.

    Training and practice are required to conduct a valid and reliable assessment of ROM. Clinicians should be aware that there is a range of error inherent in all methods. Also, such issues as patient positioning, patient motivation and proper interpretation of the instrument must be addressed. The cost of measuring devices can range from $15.00 to many thousands of dollars depending on the sophistication. Done skilfully, measurement of ROM is generally safe. However, poor reliability and sensitivity limit the usefulness of the measure.

    ii) Thermography:

    Thermography is the recording of heat from the body. There are many devices including sophisticated computer-assisted infrared imaging instruments, liquid crystal sheets and a variety of hand-held instruments (many traditional to chiropractic practice) which use a thermocouple (thermoelectric or bioelectric) contact with the skin.

    The accuracy of thermographic devices is influenced by room temperature, ambient infrared radiation materials on the skin surface and pressure (Pochaczevsky 1987). The few reliability studies that exist are not particularly encouraging nor conclusive (Meeker 1986, Plaugher 1991, DeBoer 1985, Keating 1990.) No randomised controlled trials have been done using thermography as an outcome measure. There have been some published reports of thermographic changes while under conservative care, (Diakow 1992, Sucher 1990, Kelso 1982, Diebert 1972, Brand 1982), but these have been uncontrolled, non-blinded, small sample observational efforts at best.

    Standardized examination protocols are just now being established (Vlasuk 1992) for infrared and liquid crystal procedures. Generally these are detailed and require technical expertise. There is little published standardization for the small hand-held devices.

    iii) Muscle Function:

    a) Muscle Function Using Automated Means

    The evaluation of muscle function encompasses a number of parameters: strength, work, power and endurance (Sapega 1990). Several modes of muscle contraction can be tested separately. These are termed isotonic, isokinetic and isometric. The distinctions centre on the nature of the applied load or the velocity and direction of change in the length of the muscle. Concentric contractions indicate shortening of the muscle whereas eccentric contractions occur as the muscle is lengthening. Several versions of sophisticated machines can now measure various combinations of these muscle function parameters in the extremities and in the spine.

    The reliability of muscle testing has been assessed with a dynamometer in a chiropractic setting (Hsieh 1991). The authors concluded that the "patient initiated" method yielded satisfactory scores for tests of the iliopsoas, the clavicular portion of the pectoralis major and the external rotators of the hip. Dynamometers have shown fair to good reliability in other studies (Sapega 1990).

    Several factors can affect the validity and reliability of muscle function testing. These include but are not limited to: Stabilization and positioning of the body, velocity of the test movements, gravitational influences, familiarity with the testing procedure, inertial forces, calibration, time of day, and patient motivation (Sapega 1990).

    The different methods of instrumented muscle function have advantages and disadvantages. Most have adequate reliability when strict protocols are followed. Further, most have the ability to demonstrate changes in patients undergoing exercise or musculoskeletal rehabilitation.

    b) Muscle Function Tested Using Manual Methods

    Manual muscle testing procedures that are commonly used in the chiropractic profession combine elements of isometric testing with eccentric dynamic variable resistance. Manual methods are qualitative. It has been shown that examiners interpret muscular strength or weakness more on the basis of total effort exerted in overcoming the patient's resistance than on either the peak or average force (Sapega 1990). This lessens the validity of manual tests as true tests of muscle strength (Nicholas 1978). In one study, patients with as much as a 50% decrease in strength were rated as normal by manual methods (Watkins 1984). Trained examiners have found it difficult to detect differences of less than 25% between paired limbs (Beasley 1956).

    Several chiropractic techniques use a dichotomous decision ("strong" vs. "weak") process. There are no clinical reliability studies of manual muscle testing. There are no clinical trials demonstrating the value of manual muscle testing to evaluate the outcome of chiropractic care (Hseih 1991).

    Manual muscle tests are generally safe but relatively inaccurate. Instrumented methods are safe if proper protocols are followed.

    iv) Posture:

    Posture measures are defined here to include measurements of a general topographical nature. Anatomical relations include apparent limb length inequality, the shape of the spine (degree of lordosis, scoliosis, kyphosis), etc. Two studies indicate that manipulation may increase cervical lordosis measured radiographically (Leach 1983, Owens 1990). However, the clinical relevance of such changes remains controversial.

    v) Leg Length Inequality

    Apparent limb length inequality (specifically lower limb length inequality) is often used as an indication for chiropractic care. The topic has been reviewed by Mannello (1991). Reliability has been established for some methods. However, the validity of the relationship between lower limb length and the chiropractic subluxation complex has not been determined. There are no clinical trials using lower limb length measurements as outcome assessments or as a comparison to other outcome measures.

    E. Subluxation Complex

    Historical chiropractic theory holds that manipulable lesions (subluxation syndrome) may be the cause of or associated with some disease processes, especially dysfunctions of the locomotor system. Therefore chiropractic care (primarily spinal manipulation and other manual procedures directed at joints) has as one of its primary goals the reduction of the clinical findings thought to be associated with such lesions.

    If the subluxation complex is to be used as an outcome measure, it may be helpful to describe some of its components. These components include vertebral position and motion assessed radiographically and with palpation, soft tissue compliance and tenderness, change measured by muscle contraction measured by surface and needle EMG, and neurological reflex tests.

    The chiropractic subluxation complex is described as consisting of clinical signs and symptoms at a specific dysfunctional joint, or series of joints which, when manipulated, tend to diminish (Haldeman 1991, Schafer 1989).

    The chiropractic subluxation complex was first introduced in a multidisciplinary setting in 1975 at a workshop on the research status of spinal manipulative therapy, sponsored by the National Institute of Neurological Diseases and Stroke. The definition presented to the assembly was one proposed by the American Chiropractic Association: " A subluxation is the alteration of the normal dynamics, anatomical or physiological relationships of contiguous articular structures" (Haldeman 1975). The subluxation is not considered a single entity, but rather a complex of signs and symptoms manifested by specific segmental joint dysfunction with subclassifications of intersegmental disrelationships, which are amenable to spinal manipulation/adjustment (Haldeman 1991, Schafer 1989).

    Whether or not the subluxation complex is an adequate way to assess the outcome of care in relation to chiropractic treatment is now a subject of some debate (Triano 1990).

    i) Vertebral Position Assessed Radiographically:

    Traditional chiropractic theory suggests that "misalignment" of vertebrae is a cause of the subluxation syndrome. The model for this deduction was probably based on notions of normal spinal geometry, symmetry and images obtained from plain radiographs (Mootz 1989). Palpation of bony processes could also lead to clinical impression of misalignment.

    Haldeman (1991) suggests that most practitioners who take measurements of positional relationships of the spine do so in order to make a decision about the nature and direction of the manipulative thrust. Analysis of the vertebral subluxation complex is a method of directing treatment rather than the making of a diagnosis.

    To be a valid outcome measure of patient health status, spinal misalignments should theoretically reduce with therapy. In addition, reduction of these spinal misalignments should result in an improved patient health status. Several retrospective studies (Aldus and Hill 1982, Grostic and DeBoer 1982, and Anderson 1980) suggest that there are changes in upper cervical misalignment after manipulations. However Hosek (1990) found no differences between a control group and a group which had upper cervical manipulations.

    In the lumbar spine, an observational study by Plaugher (1990) suggests that a mild retrolisthesis may be reduced by chiropractic treatment. However, a clinical trial by Roberts (1978) did not detect radiographic changes in the lumbar spine in low-back pain patients.

    ii) Abnormal Segmental Motion Assessed Radiographically:

    Haas and Nyiendo (1990,1991) have questioned the validity of lateral bending radiographs for patients with low-back pain. There does not seem to be a greater prevalence of "abnormal" findings in persons with a history of low-back pain compared to those without back pain.

    Owens (1991) points out that errors in measurements due to patient re-positioning in front of the radiographic apparatus, radiographic distortion, intra-examiner reliability, as well as biological variability may be equally responsible for the variation in measurements as treatment. Owens (1991) and others (Brontford 1984) suggest the margin of error in radiographic measurement of the angular relationship of two vertebrae is in the order of one or two degrees depending on the method and portion of the spine under observation.

    One study (Keating, 1990) found no reliability of palpation for misalignment of vertebrae. There are no clinical trial outcome studies using palpation of bony landmarks as indicators of misalignment.

    iii) Abnormal Spinal Segmental Motion Assessed by Palpation:

    Assessment of abnormal vertebral motion is a logical method of outcome assessment because by definition, manipulative methods introduce forces into the body in an attempt to make tissues move. Palpation of spinal tissues is a traditional diagnostic procedure for determining the site of the manipulable lesion. Many palpatory techniques have been described (Schafer 1989). The two most commonly defined palpatory parameters are range of motion, or more precisely the inability of a joint to demonstrate an expected amount of motion in an expected plane, and the presence (or absence) of passive joint play. "Joint play" or "end feel" has been described as the manual perception of a certain elasticity or compliance when the joint has been passively stretched to its limit. Lack of joint play has been considered an indication for manipulation (Shafer 1989). Logically, the return of normal range and quality of movement of a joint should be a good outcome measure for manipulation.

    Several qualitative reviews have summarized the scientific literature on spinal palpation in chiropractic (Panzer 1991, Haas 1991). Acceptable clinical reliability has been difficult to demonstrate, although rates of agreement are better than chance. Most studies suffered from methodological flaws. Jull (1988) indicated 100% correlation between a palpating therapist's hand - determined side and level of cervical joint pathology and a determination made independently by diagnostic joint and nerve block procedures.

    Jull (1987) also published motion palpation norms for 200 healthy subjects of various ages using a five point rating scale. Age was correlated with segmental hypomobility. Intra-examiner and inter-examiner reliability was assessed with correlation coefficients ranging from 0.81 to 0.98. One study of sacroiliac joint palpation over time as patients received adjustments suggested that, as patients recovered, abnormal palpatory signs diminished (Hertzog 1991). Arkuszewski (1986) reported in a cohort study that spinal palpatory signs also diminished to a greater extent in patients receiving manipulation than in patients receiving other treatments.

    iv) Soft-Tissue Compliance and Tenderness:

    'Compliance' relates to the attribute of flexibility or "hardness" when the soft tissues are pressed with a palpating finger or with a pressure scale. In chiropractic practice tissue compliance is usually assessed manually and is therefore qualitative. Compliance can also be assessed quantitatively with a pressure gauge instrument designed to measure the distance a plunger sinks into the skin at a given weight (Fisher 1987, 1990). It is assumed that muscle tone is the primary physiology being measured, but other events such as edema may also play a role in compliance.

    Waldorf (1991) concluded that prone segmental bilateral paraspinal tissue compliance measures (averaged together for a single segmental score) had a test/retest variation of less than 10% after two weeks in normal healthy pain-free subjects. Lawson's results (1991) also suggested good clinical reliability. Another study using compliance as an outcome measure of cervical adjustments demonstrated statistically significant changes in the lumbar paraspinal area (Nansel in press). Fischer (1987) documented increases in tissue compliance in a small sample of patients undergoing physical therapy.

    'Tenderness' is the sensation of pain expressed by a subject when pressure is applied to the body. Tenderness actually refers to a supposed hypersensitivity to pressure, although what this means quantitatively is rarely defined. A more precise term is 'pressure pain tolerance' (PPT). This can be further subdivided into threshold PPT (the point where an initial sensation of discomfort is felt) or maximum PPT (the point at which the patient cannot stand additional pressure stimulation). Tenderness or PPT threshold is one of the major palpatory signs used by practitioners for diagnostic and treatment assessment purposes. Most of the time clinical assessments are qualitative, but quantitative measurements can be made with an algometer. An algometer (pressure pain meter) measures the amount of pressure a patient can endure before a pain sensation is elicited. The amount of pressure is then recorded.

    Some tenderness norms have been published (Simms 1988, Fischer 1987), but these are based upon small relatively unrepresentative population samples. Clinical reliability of tenderness measures has been supported with studies by Reeves (1986), Ohrbach (1989), who used an algometer, and Keating (1990), who tested digital palpation.

    Vernon (1990) measured pressure pain tolerance with an algometer in cervical paraspinal soft tissues before and after cervical adjustments in a small group of patients. Compared to a control group receiving mobilization, the adjusted group demonstrated a dramatic increase in pressure tolerance. This suggests that quantitative measurements of tenderness are responsive to manual treatments. Fischer (1988) documented decreases in tenderness with physical therapy. In addition Jaeger (1986) indicated decreases in sensitivity in myofascial trigger points with passive stretch therapy.

    Tissue compliance and pressure pain tolerance assessments, whether measured by palpation or with suitable instruments, can be incorporated in physical examination procedures with relative ease. The assessments are safe and inexpensive and appear to be responsive to conditions and treatments commonly seen in chiropractic practice. The quantitative methods are more suitable for documenting outcomes of care.

    v) Asymmetric or Hypertonic Muscle Contraction Assessed Using EMG:

    Although visual observations of postural antalgia and palpation of noncompliant soft tissue suggest muscle hypertonicity, these are rarely explanations for what is actually seen or felt. Actual measurements of muscle activity can be obtained with electromyographic (EMG) methods. Needle methods are invasive and generally are beyond the scope of primary care chiropractic in most jurisdictions. Surface methods, which use electrodes on the skin, are within the scope and have become somewhat popular in chiropractic practice.

    There is no question that surface EMG does measure some aspects of muscle activity, but it is not very muscle specific. Surface EMG tends to pick up signals from all muscular activity below the electrode. There is also a great deal of controversy about the clinical relevance, reliability and responsiveness of various surface EMG examination methods (Nouwen 1984, Triano 1991).

    A number of studies have discussed the relationship between trunk EMG and back pain (Dolce 1985). Investigators have come to conflicting conclusions - some suggest that EMG can discriminate between subjects with and without back pain, others have not been able to demonstrate discriminatory ability (Cram 1986, Nouwen 1984). The data are confusing because many different parameters of EMG have been studied in comparable research designs and with flaws in experimental design and statistical analyses.

    There are no high-quality controlled studies that have indicated that spinal segmentally specific measures of surface EMG activity are related to segmental pathophysiology of the spine (subluxation syndrome). In addition at least two studies in chiropractic settings did not support the hypothesis that findings of asymmetric paraspinal EMG can differentiate between subjects with and without a history of back pain (Meeker 1991, Leach 1991). Certain other measurements, such as the lack of "flexion relaxation response" and thoracolumbar ratios, may have clinical value (Triano 1987, Leach 1991).

    The few reliability studies of EMG analysis that exist have demonstrated adequate within-session results but poor between-session (over time) consistence (Ahern 1986, Matheson 1988). One study claiming clinical reliability with hand-held "scanning" sensors had a median Pearson's R of only 0.64 for assessments one hour apart (Cram 1990). Biederman (1984) has been very critical of the reliability of EMG assessments and has identified a number of important sources of error.

    Responsiveness has been assessed in studies with biofeedback therapy (Nouwen, 1984) and spinal manipulation (Shambough 1987, Ellestad 1988). These studies have been criticized and none have concluded that spinal segmentally specific changes have occurred as a result of treatment. Overall EMG activity did apparently decline.

    Equipment varies from relatively simple hand-held devices to computer driven recording systems that yield a multitude of data. Training is necessary to conduct a valid examination, which can be time-consuming to perform properly. There is very little standardization of examination procedures at this time. Surface EMG measurements are generally safe.

    vi) Reflex Testing:

    A number of chiropractic approaches use supposed reflexes to test for the existence of a subluxation complex. Some of the more well-known are termed "isolation" tests (Activator Methods 1985), the "arm-fossa" test (De Jarnette 1984), vertebral "challenge" (Walther 1988), and "therapy localization" (Walther, 1988). Generally these tests rely upon digital stimulation of spinal or paraspinal tissues to cause a change in apparent leg position or muscle function to indicate a positive finding.

    Youngquist (1989) reported Kappa co-efficients over 0.50 for interexaminer agreement on the presence of a cervical subluxation complex with the "isolation test" taught by Activator Methods. The study design has been criticized, however, and there are no clinical trials using the "isolation test" as an outcome assessment.

    LeBouef (1990) reported that the positive results of the arm-fossa test were statistically different between lumbar symptomatic and non-lumbar symptomatic patients. Still, the percentage of false-negative tests results was 40%. In additional study LeBouef (1992) concluded that 18 assessment procedures including the arm-fossa test were unlikely to be reproducible enough to constitute useful clinical procedures. There are no studies of the use of the arm-fossa test as an outcome assessment of chiropractic care.

    There are no peer-reviewed studies of validity, reliability, or responsiveness to care which support the use of the "challenge" or the "therapy localization" procedure. Triano (1973) examined muscle testing using sublingual substance challenge testing. He was unable to demonstrate any reliability in the procedure.

    V. ASSESSMENT CRITERIA

    Rating System 1 and 2 assessment criteria are used in this chapter. For an explanation of this system (see p. xxiii).

    VI. RECOMMENDATIONS (GUIDELINES)

    The recommendations on the following procedures or methods refer specifically to their use as outcome assessments and not necessarily to their use for other clinical purposes such as for diagnosis, prognosis, or for designing treatment plans.

    A. Functional Outcome Assessments (by questionnaire)

    11.1 As a category, functional outcome assessments of everyday tasks are very suitable for evaluating treatment of dysfunctions of the neuromusculoskeletal system. Many valid and reliable questionnaires are available and the choice is dependent on the location of the patient's complaint.

    Rating: Established
    Evidence: Class I, II and III
    Consensus Level: 1

    B. Patient Perception Outcomes

    (i) Pain Indices:

    11.2 Pain measurement is generally a relevant, valid, reliable, responsive, and safe outcome assessment. Practicality may vary depending on the specific procedure used.

    Rating: Established
    Evidence: Class I, II, III
    Consensus Level: 1

    (ii) Patient Satisfaction:

    11.3 Patient satisfaction measures are an important marker of quality and are useful in clinical practice. Satisfaction is best assessed using standard questionnaires measuring a number of dimensions.

    Rating: Established
    Evidence: Class I, II, III
    Consensus Level: 1

    C. General Health Assessments

    11.4 As a category of outcomes, it is possible and desirable to assess general health. The measures are safe; some are more practical than others. General health assessments should be used along with condition specific assessments.

    Rating: Established
    Evidence: Class I, II, III
    Consensus Level: 1

    D. Physiological Outcomes:

    (i) Range of Motion:

    11.5 As an outcome measure, range of motion assessment is considered to be safe and effective. Selection of the method should be dependent on the practicality, reliability and validity of the instrument.

    Rating: Established
    Evidence: Class I, II, III
    Consensus Level: 1

    (ii) Thermography:

    (a) Thermocouple Devices:

    11.6 While this method is safe, there is no evidence to support a claim of effectiveness as an outcome measure.

    Rating: Doubtful
    Evidence: Class II, III
    Consensus Level: 2

    (b) Infrared Thermography

    11.7 This procedure is safe and is used in determining areas of varying surface temperatures.

    Rating: Equivocal to promising
    Evidence: Class II, III
    Consensus Level: 1

    (iii) Muscle Function:

    (a) Muscle Function Using Automated Means

    1. Isometric Muscle Testing

    11.8 Isometric Strength Testing Instruments are valid and reliable methods of determining the force of muscle contraction without change in muscle length.

    Rating: Established
    Evidence: Class I, II, III
    Consensus Level: 1

    2. Isokinetic Muscle Strength Testing Instruments

    11.9 Isokinetic Muscle Strength Testing Instruments are used as a means of measuring the torque generated with a maximal muscle contraction with a constant velocity and arc of movement.

    (a) For Use in Sports Injury Assessment and Rehabilitation

    Rating: Established
    Evidence: Class II, III
    Consensus Level: 1

    (b) For Use in Spinal Assessment

    Rating: Promising
    Evidence: Class II, III
    Consensus Level: 1

    (b) Muscle Function Using Manual Methods

    11.10 Although manual isometric methods of analysis of muscle strength are frequently used in neurological examinations, they lack sensitivity.

    Rating: Equivocal
    Evidence: Class II, III
    Consensus Level: 1

    (iv) Postural Evaluations:

    11.11 Certain postural parameters may be responsive to treatment. Validity, reliability and relevance issues require further investigation.

    Rating: Promising
    Evidence: Class II, III
    Consensus Level: 1

    (v) Apparent Leg Length Inequality

    11.12 The use of relative leg length inequality as an outcome measure shows some reliability but there is no evidence to support its validity.

    Rating: Equivocal
    Evidence: Class II, III
    Consensus Level: 1

    E. Subluxation Syndrome:

    The subluxation syndrome provides decision-making information for application of chiropractic treatment methods, primarily adjustments and manipulation. Regarding outcome assessments, the various components of the subluxation complex must be considered separately. These are discussed below.

    (i) Vertebral Position Assessed Radiographically:

    11.13 The literature supporting the clinical relevance of small changes in vertebral position is conflicting. The risk/benefit ratio of using radiographs (ionizing radiation) solely for measuring vertebral position as an outcome assessment requires further research.

    Rating: Investigational
    Evidence: Class II, III
    Consensus Level: 2

    (ii) Abnormal Segmental Motion Assessed Radiographically

    11.14 The literature supporting the clinical relevance of small changes in abnormal segmental motion assessed radiographically is conflicting. The risk/benefit ratio of using radiographs (ionizing radiation) for measuring vertebral motion as an outcome assessment requires further research.

    (a) Rating: Investigational to Equivocal for the Cervical Spine

    Evidence: Class II, III
    Consensus Level: 2

    (b) Rating: Investigational for other areas of the spine.

    Evidence: Class II, III
    Consensus Level: 2

    (iii) Abnormal Segmental Motion Assessed by Palpation:

    11.15 There are few validity studies of joint palpation as an outcome measure, although the existing literature on reliability is inconclusive. There are studies suggesting that palpatory signs improve with treatment, but degree of responsiveness has been difficult to quantify.

    Rating: Promising
    Evidence: Class II, III
    Consensus Level: 1

    (iv) Soft-Tissue Compliance and Tenderness:

    11.16 Clinical studies indicate a relationship between tenderness and painful neuromusculoskeletal conditions. Clinical reliability has been established. Compliance and tenderness appear to be responsive to treatment. Algometer, tissue compliance meters, and palpatory methods appear to be practical.

    Rating: Promising
    Evidence: Class I, II, III
    Consensus Level: 1

    (v) Asymmetric or Hypertonic Muscle Contraction:

    11.17 Surface EMG procedures including scanning and fixed electrodes measure some aspects of muscle activity. However, the responsiveness of EMG measurements to treatment has not been confirmed experimentally.

    (a) Rating: Equivocal (for fixed electrodes)

    Evidence: Class I, II, III
    Consensus Level: 1

    (b) Rating: Investigational (for Scanning EMG)

    Evidence: Class II, III
    Consensus Level: 2

    (vi) Reflex Testing:

    11.18 The methods are not supported by the literature as outcome measures.

    Rating: Inappropriate
    Evidence: Class II, III
    Consensus Level: 1

    F. Principles of Application

    11.19 Outcome assessments should be performed and interpreted by trained and qualified individuals.

    Rating: Necessary
    Evidence: Class II, III
    Consensus Level: 1

    11.20 Only valid and reliable outcome measures should be used when assessing the effectiveness of different modes of treatment.

    Rating: Necessary
    Evidence: Class I, II, III
    Consensus Level: 1

    11.21 Patient outcomes should be assessed at appropriate intervals during case management depending on the nature of the condition and the patient's progress.

    Rating: Necessary
    Evidence: Class II,III
    Consensus Level: 1

    11.22 General health outcomes as well as condition-specific outcomes of chiropractic care should be assessed using standardized methods.

    Rating: Recommended
    Evidence: Class II, III
    Consensus Level: 1

    VII. COMMENTS, SUMMARY OR CONCLUSION

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    IX. MINORITY OPINIONS

    None

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