MANUAL EXAMINATION OF THE SPINE: A SYSTEMATIC CRITICAL LITERATURE REVIEW OF REPRODUCIBILITY
 
   

Manual Examination of the Spine: A Systematic
Critical Literature Review of Reproducibility

This section is compiled by Frank M. Painter, D.C.
Send all comments or additions to:
    Frankp@chiro.org
 
   

FROM:   J Manipulative Physiol Ther 2006 (Jul); 29 (6): 475–485 ~ FULL TEXT


Mette Jensen Stochkendahl, Henrik Wulff Christensen, Jan Hartvigsen, Werner Vach, Mitchell Haas, Lise Hestbaek, Alan Adams, Gert Bronfort

Nordic Institute of Chiropractic and Clinical Biomechanics Research Department,
Part of Clinical Locomotion Science,
Odense, Denmark



Objective:   Poor reproducibility of spinal palpation has been reported in previously published literature, and authors of recent reviews have posted criticism on study quality. This article critically analyzes the literature pertaining to the inter- and intraobserver reproducibility of spinal palpation to investigate the consistency of study results and assess the level of evidence for reproducibility.

Methods:   Systematic review and meta-analysis were performed on relevant literature published from 1965 to 2005, identified using the electronic databases MEDLINE, MANTIS, and CINAHL and checking of reference lists. Descriptive data from included articles were extracted independently by 2 reviewers. A 6-point scale was constructed to assess the methodological quality of original studies. A meta-analysis was conducted among the high-quality studies to investigate the consistency of data, separately on motion palpation, static palpation, osseous pain, soft tissue pain, soft tissue changes, and global assessment. A standardized method was used to determine the level of evidence.

Results:   The quality score of 48 included studies ranged from 0% to 100%. There was strong evidence that the interobserver reproducibility of osseous and soft tissue pain is clinically acceptable (kappa > or = 0.4) and that intraobserver reproducibility of soft tissue pain and global assessment are clinically acceptable. Other spinal procedures are either not reproducible or the evidence is conflicting or preliminary.

Key Indexing Terms   Reproducibility of Results, Palpation, Literature Review, Diagnostic Tests, Spine, Meta-Analysis



From the FULL TEXT Article:

Background

Biomechanical dysfunction is thought to be an important contributor to spinal pain, and manual palpation is a widely used procedure for the diagnosis of such dysfunctions among providers of manual medicine. [1-3] Contrary to the expectations of many clinicians, unacceptable levels of reproducibility have been shown in the majority of the previously published literature, and authors of newer reviews have questioned the utility of manual examination procedures in spinal diagnosis altogether. [4-7]

Severe criticism has been posted on the design of the original studies, including

the use of asymptomatic subjects, [4, 5]

inexperienced observers, [5]

parallel testing, [4]

unclear definitions of positive findings and rating scales, [4, 6]

weak description of study results, [4, 5, 7] and

the need for improvement in overall study quality. [4, 7]

Furthermore, the dependence of Cohen's κ (the most widely used statistical method in studies on reproducibility) on the prevalence of positive findings, and the composition of the study population has been the subject of discussion. [8, 9]

Unfortunately, these reviews themselves have important limitations. For instance, some deal with only a minority of manual examination procedures such as chiropractic procedures only, [4] 1 spinal region, [4, 6, 10] or motion palpation only. [5] In only 3 reviews were a predefined quality system applied to assess study quality, [4, 6, 7] and in none of the reviews were both the number of studies, the methodological quality, and the consistency of the outcomes considered, as recommended by van Tulder and others. [11-13] Finally, in none of these reviews was the impact of the predefined criteria on the conclusions tested. Therefore, the value of palpation as a diagnostic tool is, at present, still unknown and so are the abilities of practitioners of manual therapy to reliably diagnose spinal dysfunctions using palpation.

We therefore decided that another systematic review taking into account the above issues was warranted. Furthermore, a meta-analysis including comparable studies of adequate methodological standard and assessment of the consistency of study outcomes would be highly useful. The purpose of this paper is therefore to systematically review and critically assess the design and statistical methodology of the literature pertaining to reproducibility of spinal palpation adopting standardized criteria for judging diagnostic studies. A meta-analysis was conducted to evaluate consistency of study outcomes. Finally, the level of evidence for the reproducibility of spinal palpation was determined.



Discussion

      Summary of Results

After reviewing studies dealing with reproducibility of manual palpation of the entire spine, including the SI joints, we found strong evidence for clinically acceptable reproducibility both within and between observers for palpation of osseous and soft tissue pain (STP) and within the same observer for global assessment (GA). Strong evidence for clinically unacceptable levels of reproducibility for intra- and interobserver global assessment, motion palpation (MP) and soft tissue changes (STC) was found. Intraobserver reproducibility was consistently higher than interobserver reproducibility, and reproducibility of palpation for pain response was consistently higher than reproducibility of palpation for motion.

The most recent and comprehensive review evaluating the reproducibility of spinal palpation by Seffinger et al [7] applied different inclusion and general review criteria, and thus, only 27 of 44 articles and 9 of 19 high-quality articles included in this review were evaluated. Furthermore, we included several more recent publications and articles dealing with the SI joints, GA, and evaluated single results from multiple test regimens. Our conclusions are based on predefined criteria and an evaluation of consistency of high-quality studies, a method not previously applied, whereas the conclusions by Seffinger et al [7] were based on both high- and low-quality studies without an evaluation of consistency. The authors concluded that pain provocation tests are most reliable, and soft tissue paraspinal palpatory diagnostic test is not reliable. Among the 12 highest-quality articles, pain provocation, motion, and landmark location tests were reliable within the same observer, but not always among observers under similar conditions. Overall, examiner' discipline, experience level, consensus on procedures used, training, or the use of symptomatic subjects did not improve reliability. This is in agreement with our findings. Furthermore, we conclude that palpation of pain is reproducible both within and among observers, whereas MP may be reproducible within the same observer.

      Methodological and Clinical Considerations

The experimental design of reproducibility studies has been criticized in previous reviews, [4-7, 68-71] and we found that 26 of 48 articles were of low methodological quality, had invalid statistical methods, or insufficient reporting of palpation procedures or test results.

Comparability of the studies included in a review is the important requirement to ensure valid generalizations. We ensured comparability with respect to the palpation procedures used, but the studies were rather heterogeneous with respect to characteristics such as definition of positive findings, segmental region, standardization, occupation, experience, symptomatic status of test population, and parallel testing. However, our investigation showed that most study characteristics had little influence on the study results, with the exception of the application condition. Especially, standing palpation was associated with very low κ values. Among the reviewed studies, standing palpation is used solely in the “Gillet test” of SI biomechanical dysfunction, and only 2 studies reporting this condition were included in our analysis. [39, 59] However, both contributed to the evaluation of the inter- and intraobserver agreement of MP. If we remove these 2 studies, then the average κ for the interobserver agreement increases to 0.19 (0.13-0.26), and the intraobserver agreement increases to 0.44 (0.14-0.73), such that the intraobserver agreement of MP can be regarded as acceptable.

Poor reproducibility of MP may reflect the design of reproducibility studies, rather than the quality of the palpation procedure. [29, 30, 72] Greater reproducibility may be attained by allowing positive findings in a neighboring spinal segment to count in assessing agreement. [29] However, this implies that we define a new, different diagnostic test which, then, requires a clinical rationale of test meaningfulness, beyond just an increase in κ values. [8] Further, parallel testing (test regimens) seems to aid the observer in making the clinical decision, thus enhancing reproducibility; [30, 42] a tendency we could also observe in our data. The acceptable intraobserver reproducibility for GA is also in line with this finding. However, when evaluating a combination of tests, information is only given about the reproducibility of the single test as part of this exact combination of tests. [14, 73] Moreover, we must be aware that conclusions on a single test from a study involving several tests may be only valid if the test is applied as part of this exact combination of tests. From a clinical perspective, increased reproducibility with parallel testing indicates that at this point, clinicians should not base their diagnosis on a single clinical examination finding such as palpation but, rather, conduct a range of tests. It is, however, premature to make clinical guidelines on how to use palpation because many aspects of palpation, such as the validity, still need to be investigated.

The reproducibility of palpation for pain response is consistently higher than palpation for motion and, consistently, substantially higher within an observer than among different observers. However, both palpatory pain studies and intraobserver studies in general have inherent problems with blinding of observers. In intraobserver studies, conscious and unconscious cues may render blinding of the observers impossible, and the independence of measures can not be guaranteed. In palpatory pain studies, blinding of subjects is impossible. Both situations imply the risk of overestimating reproducibility. It should also be noted that intraobserver reproducibility is somewhat higher than interobserver reproducibility by definition (depending on the magnitude of observer by subject interaction). [74]

A dilemma between high internal validity and clinical applicability arises when designing studies of reproducibility. For example, training studies contrast maximal (ideal) reproducibility with actual reproducibility in practice. To enhance the internal validity, rigid testing conditions should be set up with considerations to blinding, randomization, standardization and training, and parallel testing. However, rigid enforcement of testing condition often diverges from the clinical situation and, hence, may reduce the external validity. In a clinical situation, a mix of both asymptomatic and symptomatic patients will most likely present to practitioners of manual medicine. Therefore, the study population should consist of a mix of both symptomatic and asymptomatic subjects so that the reproducibility of the testing procedure has a relation to the characteristics of the study population. [14] Finally, in spite of the use in every day clinical routines, test procedures do not always necessarily evaluate the clinical entity it is intended to evaluate, and it is therefore important to discuss the content of the test procedure. [14, 75]

      Statistical Considerations

κ is widely accepted as the statistical method of choice for evaluating agreement between 2 observers for a binary classification. [8] It is, however, not without problems to use κ as the sole measure of observer agreement because information is lost when a 4-fold table is summarized into 1 number. Consequently, we do not know whether it is due to a difference in prevalence estimates between observers, or whether observers lack agreement in spite of similar prevalence if a moderate κ value is obtained in a study of reproducibility.

κ has been criticized for its dependence on the prevalence of positive findings, which limits its usefulness in meta-analyses, because studies with varying prevalence are typically compared. However, the composition of the study population may have greater impact on κ than the prevalence of positive findings. [9] Both a binary outcome and a reported κ value were required for studies to be part of our meta-analysis. However, binary outcomes may vary according to the definition of positive findings (ie, prevalence is directly dependent on the definition of positive findings). For example, if the observer is asked to identify any hypomobile segment(s) in a spinal region, the prevalence can vary from 0% to 100%, depending on the study population. If the observer is to identify the most hypomobile segment, the overall prevalence of positive findings will be 100%, but at any particular segment under investigation, the prevalence of the most hypomobile can be 0% to 100%. However, we found no association between the prevalence of positive findings and κ values. This supports that the composition of the study populations is probably of greater importance than the prevalence of positive findings, as suggested by Vach. [9]

Different words and schemes have been used to evaluate the strength of reproducibility, but there are no definitive guidelines for interpreting good concordance. [8, 76] Moreover, little research has been done to establish minimal, clinically acceptable reproducibility, and perhaps more important than qualifying the strength of concordance, the quantitative reproducibility indices need to be evaluated in terms of their clinical application. [8]

      Limitations of this Review

Different methodologies have been advocated for systematic reviews of trials addressing therapeutic efficacy, [12] but little consensus exists when it comes to assessing the quality of reproducibility studies. We have chosen to evaluate the strength of evidence based on a best-evidence synthesis method, and this is one of the main differences between this review and previously published reviews on the same topic. Heterogeneity across studies, in terms of test procedures, inclusion criteria, study design and presentation of results, may be masked by the best-evidence approach. Considerable heterogeneity in study characteristics was noted across studies included in this review. However, despite this heterogeneity, the meta-analysis showed very consistent overall findings and only moderate impact of the specific design characteristics on the study outcomes.

The exclusion from the meta-analysis of studies that did not report a binary outcome is another important difference between this and previous reviews. To compare studies of reproducibility, the same type of outcome and method of statistics must be applied. On this account, we had to exclude 5 high-quality studies from the meta-analysis. Results from these studies are not directly comparable to the included studies, but all 5 articles show results with similar trends of low interobserver agreement on MP and higher interobserver agreement on evaluation of pain; they were included in the level of evidence assessment. The restricted number of articles causes the strength of evidence to be preliminary or nonexistent in 3 categories. In return, the power of the conclusions with respect to pain and motion testing is compelling. However, results were, in some categories, based on a relatively small number of original studies, making the conclusions very sensitive to just a few future high-quality studies with different results.

A κ value was reported in all high-quality studies using a binary classification. Hence, there was no need to calculate these from a published 4-fold table. No attempts were made to retrieve additional, original results or materials from the primary authors.

Although every effort was made to find all published reproducibility studies, selection bias may have occurred because we included only English-language articles. Publication bias may have resulted in an overestimation of test reproducibility because studies arriving at positive conclusions are more likely to get published. [77, 78] Furthermore, reviewer bias is also a possible limitation of this review. Reviewers were not blinded to the authors or the results of the individual trials when the methodological scoring was performed because of our familiarity with the literature.

Despite acceptable study quality according to our criteria, many trials still had methodological limitations or, at best, inadequate reporting of methods. Nonetheless, reproducibility of spinal manual palpation has been very thoroughly investigated and more than 40 original articles have been evaluated in this review. However, to shed light on the clinical usefulness of palpation, the validity needs to be investigated, and new innovative research that addresses the concomitant problems of selecting a golden standard in motion testing is warranted. Future research should also address the question of palpation in the overall assessment of neck and back pain patients and the importance of palpation as part of the complete clinical evaluation of patients.



Conclusions

Palpation for pain is reproducible at a clinically acceptable level, both within the same observer and among observers. Palpation for global assessment (GA) is reproducible within the same observer but not among different observers. The level of evidence to support these conclusions is strong. The reproducibility of motion palpation (MP), soft tissue changes (STC) and static palpation (SP) is not clinically acceptable.

The level of evidence is strong for interobserver reproducibility of MP and STC, whereas no evidence or conflicting evidence exists for SP and intraobserver reproducibility of STC. Results are overall robust with respect to the predefined levels of acceptable quality. However, the results are sensitive to changes in the preset level of clinically acceptable reproducibility and to the number of included studies.



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