Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial

Tom Petersen, Robin Christensen, Carsten Juhl, Tom Petersen, Robin Christensen, Carsten Juhl

Abstract

Background: Reports vary considerably concerning characteristics of patients who will respond to mobilizing exercises or manipulation. The objective of this prospective cohort study was to identify characteristics of patients with a changeable lumbar condition, i.e. presenting with centralization or peripheralization, that were likely to benefit the most from either the McKenzie method or spinal manipulation.

Methods: 350 patients with chronic low back pain were randomized to either the McKenzie method or manipulation. The possible effect modifiers were age, severity of leg pain, pain-distribution, nerve root involvement, duration of symptoms, and centralization of symptoms. The primary outcome was the number of patients reporting success at two months follow-up. The values of the dichotomized predictors were tested according to the prespecified analysis plan.

Results: No predictors were found to produce a statistically significant interaction effect. The McKenzie method was superior to manipulation across all subgroups, thus the probability of success was consistently in favor of this treatment independent of predictor observed. When the two strongest predictors, nerve root involvement and peripheralization, were combined, the chance of success was relative risk 10.5 (95% CI 0.71-155.43) for the McKenzie method and 1.23 (95% CI 1.03-1.46) for manipulation (P = 0.11 for interaction effect).

Conclusions: We did not find any baseline variables which were statistically significant effect modifiers in predicting different response to either McKenzie treatment or spinal manipulation when compared to each other. However, we did identify nerve root involvement and peripheralization to produce differences in response to McKenzie treatment compared to manipulation that appear to be clinically important. These findings need testing in larger studies.

Trial registration: Clinicaltrials.gov: NCT00939107.

Figures

Figure 1
Figure 1
Treatment effect modified by predictors. The top point estimate and confidence intervals indicate overall effect without subgrouping. Subsequent pairs of point estimates and confidence intervals show the chances of treatment success following MDT vs spinal manipulation in six subgroups.
Figure 2
Figure 2
Impact of the two clinically important predictors combined on treatment effect. RR = Relative Risk with Yates correction.

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