The McKenzie Method Compared with Manipulation When
Used Adjunctive to Information and Advice in Low
Back Pain Patients Presenting with Centralization
or Peripheralization: A Randomized Controlled TrialThis section is compiled by Frank M. Painter, D.C.
Send all comments or additions to: Frankp@chiro.org
FROM: Spine (Phila Pa 1976) 2011 (Nov 15); 36 (24): 1999-2010 ~ FULL TEXT
Petersen, Tom PT, PhD; Larsen, Kristian PT, PhD; Nordsteen, Jan DC, MPH; Olsen, Steen PT; Fournier, Gilles MD, DC, BSc; Jacobsen, Soren MD, DrMsci
Back Center Copenhagen,
Copenhagen, Denmark.
Study design: Randomized controlled trial.
Objective: To compare the effects of the McKenzie method performed by certified therapists with spinal manipulation performed by chiropractors when used adjunctive to information and advice.
Summary of background data: Recent guidelines recommend a structured exercise program tailored to the individual patient as well as manual therapy for the treatment of persistent low back pain. There is presently insufficient evidence to recommend the use of specific decision methods tailoring specific therapies to clinical subgroups of patients in primary care.
Methods: A total of 350 patients suffering from low back pain with a duration of more than 6 weeks who presented with centralization or peripheralization of symptoms with or without signs of nerve root involvement, were enrolled in the trial. Main outcome was number of patients with treatment success defined as a reduction of at least 5 points or an absolute score below 5 points on the Roland Morris Questionnaire. Secondary outcomes were reduction in disability and pain, global perceived effect, general health, mental health, lost work time, and medical care utilization.
Results: Both treatment groups showed clinically meaningful improvements in this study. At 2 months follow-up, the McKenzie treatment was superior to manipulation with respect to the number of patients who reported success after treatment (71% and 59%, respectively) (odds ratio 0.58, 95% confidence interval [CI] 0.36 to 0.91, P = 0.018). The number needed to treat with the McKenzie method was 7 (95% CI 4 to 47). The McKenzie group showed improvement in level of disability compared to the manipulation group reaching a statistical significance at 2 and 12 months follow-up (mean difference 1.5, 95% CI 0.2 to 2.8, P = 0.022 and 1.5, 95% CI 0.2 to 2.9, P = 0.030, respectively). There was also a significant difference of 13% in number of patients reporting global perceived effect at end of treatment (P = 0.016). None of the other secondary outcomes showed statistically significant differences.
Conclusion: In patients with low back pain for more than 6 weeks presenting with centralization or peripheralization of symptoms, we found the McKenzie method to be slightly more effective than manipulation when used adjunctive to information and advice.
From the FULL TEXT Article:
Background
Disability related to low back pain (LBP) is a major problem in the Western World. [1, 2] About 60% to 65% of the Nordic population are likely to experience LBP during their lifetime and 45% to 55% of adults will experience pain within a 12–month period. [3] Studies from a variety of countries investigating the long-term course of LBP show that most patients will improve rapidly. [4] Further improvement is apparent until about 3 months. Thereafter, levels for pain, disability, and return to work remains almost constant. Six months after an episode of LBP, 60% to 70% of patients will have experienced relapses of pain and 16% will be sick-listed. As much as 62% will still be experiencing pain after 12 months. [4, 5]
The most recent published consensus reports for the treatment of patients with persistent nonspecific low back pain (NSLBP) recommend a program that focuses on self-management after initial advice and information. These patients should also be offered a structured exercise program tailored to the individual patient and other methods such as manipulation. [6, 7]
Previous studies have compared the effect of the McKenzie method, also called Mechanical Diagnosis and Therapy (MDT), with that of manipulation in mixed populations of patients with acute and subacute symptoms of NSLBP and found no difference in outcome. [8, 9]
Recently, the need for studies testing the effect of treatment strategies for diagnostic subgroups of patients with NSLBP in primary care has been emphasized [10–12] based on the hypothesis that subgrouping methods improve decision-making toward the most effective management strategies. Although initial data show promise, there is presently insufficient evidence to recommend the use of specific decision methods tailoring specific therapies in primary care. [7]
Three randomized studies have tested the effects of the McKenzie method versus spinal manipulation in a subgroup of patients with predominantly acute or subacute NSLBP that responded favorably to end range motions during physical examination. [13–15] The conclusions drawn from these studies were not in concurrence and they were limited by a low methodologic quality. To pursue the idea of subgrouping further, we wanted to focus on a more homogeneous clinical subgroup of patients by the inclusion of patients with NSLBP characterized by centralization or peripheralization of symptoms during physical examination. To control for the benign natural course of LBP in the early phases, patients with persistent pain were targeted. In addition, we wanted to increase the relevance of the study for daily practice by incorporating the latest recommendations regarding self-management in both the treatment arms.
The objective of this study was to compare the effects of the McKenzie method with those of spinal manipulation when used adjunctive to information and advice in a clinical subgroup of patients with LBP of more than 6 weeks duration.
Discussion
In both the McKenzie and the manipulation group, longterm improvements were observed. Although between-group differences were not particularly large at all follow-ups, the McKenzie method appeared to be the more favorable method of treatment. The sensitivity analysis showed that the results were robust and the between-group differences remained after adjustment for predefined prognostic variables. The difference in number of patients reporting success after treatment was slightly below the predefined clinical relevant level of 15% and furthermore the difference in reduction of disability was below the 2.5 points recommended by others. [26]
Number of patients with treatment success was chosen as the main outcome measure in this trial based on the belief that clinicians need to be able to tell patients what their chances are of obtaining a specific outcome. The reports of mean improvement are useful, but around every mean value there will be patients who fare better than the mean and those who fare worse. In our definition of treatment success, we used a strict definition of minimal clinical important difference on RMDQ in the upper end of the recommended interval from 2.5 to 5 points. [26] A lack of a nontreatment control group in this study means that conclusions cannot be drawn as to whether our results can be explained by the natural history of back pain or nonspecific effects such as extra attention. However, the long pretreatment duration of symptoms and the minimal change in disability across two baseline measures in the Regression to The Mean analysis suggest that the patient sample was in a stable condition and that an important improvement without intervention should not be expected. Furthermore, an attempt was made to distribute attention bias evenly between groups by securing that all practitioners were dedicated to the type of treatment they performed and the patients in both groups received the same amount of contact. A limitation of the study is a relatively high withdrawal rate during intervention.
The withdrawal rate covers patients who decided to discontinue treatment during the course as well as patients that were excluded by decision of the practitioner. The majority withdrew or was excluded for reasons likely to be related to lack of treatment effect (43 patients in the manipulation group vs. [28] in the McKenzie group). The difference in withdrawal rate between groups supports the conclusion that the McKenzie treatment was the most suitable for our patient sample. A difference in proportions of this magnitude is not likely to be explained by an unequal distribution of candidates for The McKenzie method and Manipulation withdrawal/exclusion as an effect of randomization especially because the patients’ expectations to improvement were similar in the groups. Most of these patients responded to follow-up questionnaires and were included in the intention-to-treat analysis. This procedure appears reasonable also from a clinical perspective, inasmuch as there was a large difference between groups in the number of patients withdrawing or already excluded after the first visit (16 patients in the manipulation group vs. 1 patient in the McKenzie group) (data not presented).
Unfortunately, the enrolment of patients had to be stopped before the planned sample size was reached due to a change in overall patient care politics by decision of the management of the Back Center Copenhagen. Although the study was slightly underpowered at long-term follow-up, the narrowness of confidence intervals suggests that type II error is unlikely.
This trial compared the effectiveness of treatments commonly used in primary care. However, the generalizability of our treatment results might be hampered by the fact that clinical decision making was performed without standardization by highly skilled clinicians.
What is new in this study is the inclusion of patients with persistent LBP and a changeable symptomatology, that is, both centralizers and peripheralizers during initial screening. Based on a randomized study it has been concluded that centralizers do better than noncentralizers when treated with the McKenzie method compared to other types of treatment. [37] However, the poor outcome reported among noncentralizers in that study might be related to patients with no change in symptoms during initial examination. In our post hoc analysis of interaction, centralization was not a treatment effect modifier. Also the value of centralization as a prognostic factor for outcome (regardless of treatment) shown in earlier studies [20] has been challenged by recent published data. [38, 39] The question remains: are centralization and peripheralization prognostic factors regardless of treatment or are they treatment effect modifiers related to a specific treatment?
We used particularly strict criteria for centralization or peripheralization of symptoms 16 because these have demonstrated an association with positive discography. [18] We recognize that the diagnostic value of discography is controversial, [40] however, when performed with determination of a control disc, there appears to be no other means of directly challenging the intervertebral disc to detect if it is the source of LBP. [41] The majority of patients were classified as reducible disc syndromes based on the finding of centralization of symptoms from a distal to a more proximal body part. Although previous studies [37, 42] have used more liberal definitions of centralization, results of those studies might indicate that such a subgroup of patients would profit the most from the McKenzie method. On the other hand, a recent review concluded that patients with signs of a possible lumbar disc disease with or without nerve involvement often undergo spinal manipulative treatment in practice and the hypothesis that high-velocity spinal manipulation may be effective in these patients is supported by current evidence. [43]
In our study, the number of patients with clinical signs of nerve root involvement was distributed evenly between treatment groups, but more patients in the manipulation group were referred to surgical evaluation for this reason (nine patients in the manipulation group vs. five in the McKenzie group) (Table 2). Although this small number of patients is not likely to influence the overall outcomes, this finding suggests that the McKenzie method should be recommended as the first choice for the treatment of these patients.
The within-group results of our study might indicate that the manipulative approach to patients with centralization of peripheralization of symptoms should be considered, if the McKenzie method fails to provide improvement.
The most apparent differences between the treatments compared in this study were as follows: treatment by the McKenzie method was mainly performed by patient generated force using repeated or static movements to end range of motion in a direction that relieves the patient’s symptoms during physical examination, where as spinal manipulation was mainly performed by manually generated force using a single thrust movement with low amplitude in a direction of restricted movement as judged by clinical examination. Both treatment methods, however, intended to mobilize intervertebral spinal joints, and both were monitored by the patient’s pain response during the course of treatment. Thus, both treatments are likely to influence the same pain mechanism. This might be one of the possible explanations for the relatively modest difference between treatments in our patients.
Evidence from randomized trials in clinical subgroups of patients comparable to ours have provided promising results in patients with predominantly acute and subacute LBP. [13, 14, 37, 42] Those studies did not intent to suggest a possible pathoanatomical condition, but rather to delineate a subgroup of patients with increased chance of responding to a specifi c intervention. They have included a broader group of patients with a directional preference, that is, a favorable response to end range motion tests during physical examination regardless of whether the response was centralization or just an improvement in intensity of symptoms. The study by Long et al [37] with 2 weeks follow up found greater improvement by the McKenzie method when compared with general mobilizing and stretching exercises. The study by Browder et al [42] with 6 months follow-up suggests substantial benefit of the McKenzie method compared with lumbar strengthening exercises.
Schenk et al 14 found greater improvement by the McKenzie method as compared with that of spinal manipulation, where as Erhard et al [13] reached the opposite conclusion. Both of the latter studies, however, were hampered by a low methodologic quality (small sample size, only short-term follow-up, and/or blinding of investigator uncertain). In addition, all of the four abovementioned studies are subjected to the risk of intervention bias inasmuch as the same practitioner performed both of the treatments compared. In a recent study, Kilpikoski et al [15] performed a secondary analysis of data from their earlier published trial [9] comparing the McKenzie method with manipulation. Only patients classified as centralizers were included. Although it suffered from small sample size, the study found a tendency in favor of the McKenzie method compared with manipulation that reached a statistical significance only in reduction of disability at 6 months follow-up.
Given the promising preliminary results in the literature and the improvement rate achieved in both our treatment groups, a future research area would be to explore clinical findings that identify which patients respond better to the McKenzie method or manipulation in patients with acute, subacute, or chronic LBP. Furthermore it seems worthwhile to test the effects of a combination of the two treatments as suggested by the results of a series of case reports. [44]
Key Points
The McKenzie-method and spinal manipulation are recommended treatments for patients with persistent nonspecific LBP. Preliminary evidence from low-quality studies comparing the two interventions is promising although results from those studies have only been reported in populations with acute or subacute low back and mainly for short-term outcomes.
In patients with persistent LBP showing centralization or peripheralization of symptoms, this study found the McKenzie-method to be more effective than spinal manipulation when applied adjunctive to information and advice, although clinical relevance is questionable.
The between-group differences in outcome were most apparent 2 and 12 months after the completion of treatment. However, differences were not particularly large.
The results of this study support the value of a classification approach based on clinical examination fi ndings in the management of patients with LBP in primary care.
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