Which Exercise for Low Back Pain: A Validation Study
Condition: Chronic Low Back Pain; Non Specific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Motor control exercises; Graded activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first stage of the treatment involves assessment of symptoms and implementation of a retraining program designed to improve activity of muscles assessed to have poor control and reducing activity of any muscle identified to be overactive. Participants are taught how to contract these muscles independently from the superficial trunk muscles and progress until the patient are able to maintain isolated contractions of the target muscles. During this stage exercises for breathing control, posture of spine and lower limb and movement are performed. The second stage of the treatment involved the progression of the exercises towards more functional activities. Throughout this process the recruitment of the trunk muscles, posture, movement pattern and breathing are assessed and corrected.; The program is based on activities that each patient identify as problematic and that they cannot perform or have difficulty performing because of their back pain. The activities in the program are progressed in a time-contingent manner from the baseline assessed ability to a target goal set jointly by patient and therapist. Patients receive daily quotas and are instructed to only perform the agreed amount, even when they feel they are capable of doing more. Cognitive-behavioural principles are used to help patients overcome the natural anxiety associated with pain and activities. Physiotherapists use positive reinforcement, explain pain mechanisms and addressed negative behaviours and pain-related anxiety. A plan for managing relapses is developed between therapists and patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized into one of two groups, both of which are exercises considered part of standard care.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; mobility; physiotherapy; validation