Chronic Low Back Pain Clinical Trial
Official title:
Which Exercise for Low Back Pain? Predicting Response to Exercise Treatments for Patients With Low Back Pain: a Validation Pilot Study
Dr. Macedo and others involved in the proposed research recently conducted a study that investigated whether simple clinical characteristics could identify patients who benefit more from either motor control exercises or graded activity. Results were statistically significant and clinically relevant demonstrating that a simple questionnaire could help aid the selection of the most appropriate exercise therapy for each individual patient. Therefore, we aim to conduct a randomized controlled trial following a similar approach to the original study to validate in a different sample the results of the effect modification analysis.
Dr. Macedo and others involved in the proposed research recently conducted a study that
investigated whether simple clinical characteristics could identify patients who benefit more
from either motor control exercises or graded activity. Motor control exercises (sometimes
called lumbar stabilization exercises) and graded activity using the principles of cognitive
behavioral therapy are two popular forms of exercise therapy with evidence of effectiveness
from high quality systematic reviews, but no evidence for superiority of one approach over
the other when tested in heterogenous populations. The results of a previously published
study demonstrated that a simple 15-item questionnaire (Lumbar Spine Instability (LSI)
Questionnaire) could identify patients who responded best to either motor control exercise or
graded activity (interaction 2.72 95% CI 1.39 to 4.06, p=0.001). The results demonstrated
that for people who are LSI negative, graded activity provided a much better outcome than
motor control exercise one year post-intervention (a statistically and clinically significant
improvement of 1.96 points on a 0-10 numeric function scale; p< 0.001). In people who were
LSI positive, motor control exercise provided slightly better outcomes, compared to those
prescribed motor control exercises. It is important to note that this study was measuring
differences between treatments groups, and thus change in the scores of function presented
represent differences between groups.
However, although this clinical decision rule has the potential to transform exercise
treatment for LBP, especially given the relatively large interaction effects found,
validation in an independent sample is essential before recommending use in clinical
practice.There are three recognized steps in developing clinical decisions rules: derivation,
validation and impact evaluation. Dr. Macedo's previous study falls within the first step of
this process and the proposed study aims to address the second step; validation.
Therefore, the objective of this study is to conduct a randomized controlled trial following
a similar approach to the original study to validate in a different sample the results of the
effect modification analysis to identify baseline characteristics that predict/modify
response to treatment.
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