Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Non Specific Low Back Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Given the exercise nature of the study it is not possible to blind therapists or patients, however; assessors will remain blindedPrimary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

Background: Clinical practice guidelines consistently endorse exercise therapy for the treatment of low back pain (LBP). While exercise is more effective than no intervention, the effect size of exercise, like other treatments for LBP, is relatively small. While there are many forms of exercise ther...

Background: Clinical practice guidelines consistently endorse exercise therapy for the treatment of low back pain (LBP). While exercise is more effective than no intervention, the effect size of exercise, like other treatments for LBP, is relatively small. While there are many forms of exercise therapies available (e.g. general exercise, pilates), there is no clear evidence of superiority of one exercise over another. A widely held belief is that the small effect for exercise is due to the heterogeneity of people presenting with LBP and if individual patients could be better matched to the optimal types of exercise, then the effects of treatment would be greater.A recently published study conducted by the study investigators provided preliminary evidence supporting the hypothesis of better outcomes when patients are matched to the appropriate exercise. The study demonstrated that a simple 15-item questionnaire, the Lumbar Spine Instability Questionnaire (LSIQ), could identify patients who responded best to either of the most common exercise approaches for LBP. Participants who had low scores on the LSIQ had better outcomes with graded activity while those with higher scores had better outcomes with motor control exercise. Theoretically, motor control would work best on those that have poor coordination and control of the trunk muscles and graded activity would work best on those with unhelpful beliefs and attitudes towards back pain. Although the results of this study have the potential to transform exercise treatment for LBP, validation and confirmation off the results in a fully powered study using an independent sample is essential before recommending implementation in clinical practice. Validation and impact analysis are crucial steps in the investigation of effect modification models. Research aims: The primary aim of this study is to evaluate whether pre-identified baseline characteristics, including the LSIQ, can modify the response to two of the most prominent exercise therapies (graded activity and motor control) for non-specific LBP. The secondary aims include a cost-effectiveness analysis of a potential stratified care model. Exploratory aims include the evaluation of potential new effect modifiers that may strengthen the initial prediction model. This include measures of central pain mechanisms to differentiate nociceptive, neuropatic and nociplastic pain. Methods: Participants (414) will be recruited by primary care professionals and will be randomized (1:1) to receive either motor control exercises or graded activity. Participants will receive 12 sessions of exercise therapy,delivered by a physiotherapist, over an 8-week period. The primary outcome will be disability at 2 months measured using the Oswestry Disability Index. Secondary outcomes will be pain, function and quality of life measured at 2, 6 and 12 months. Potential effect modifiers will be the LSIQ, self-efficacy, coping strategies, kinesiophobia and measures of nociceptive pain and central sensitization. The study will follow specific guidelines for the conduction of effect modification studies. Expected outcomes: The results of this study will provide the foundation for the implementation of the study results in large scale which would significantly improve the effects of exercise for LBP. Furthermore, it will provide cost-effectiveness information to guide clinical decision making. Implementation of this approach would be simple as both treatments are already widely used and the method to identify subgroups of responders to each approach is straight forward, quick and at no cost.

Tracking Information

NCT #
NCT04283409
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • Macquarie University, Australia
  • Laval University
  • The University of Queensland
  • University of Alberta
Investigators
Principal Investigator: Luciana G Macedo, PhD McMaster University