Which Exercise for Low Back Pain: A Validation Study

Not Applicable

Completed

• Conditions: Chronic Low Back Pain; Non Specific Low Back Pain
• Interventions: Behavioral: Motor control exercises; Behavioral: Graded activity

• Registration Number: NCT03327753
• Lead Sponsor: McMaster University

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Primary Completion: 2018-09
• Study Completion: 2018-12
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients will be eligible for inclusion if they meet all of the following inclusion criteria: chronic non-specific LBP (>3 months) with or without leg pain, currently seeking care for LBP, between 18 to 80 years of age, English speaking (to allow response to the questionnaires and communication with the treating physiotherapist), Clinical assessment indicating that the participant is suitable for active exercises (by a family physician or using the Physical Activity Readiness Questionnaire), Moderate or greater pain or disability measured using question 7 or question 8 of the SF-36 Health Survey, moderate or High Risk Classification on the STarT Back Tool indicating appropriateness of physiotherapy and thus an exercise program.

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Exclusion Criteria

• Exclusion criteria will be known or suspected serious pathology, comorbidity that would prevent participation in exercise programs and scheduled for surgery during trial period.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor control exercises	Motor control exercises	A primary goal of the motor control exercise program is to regain control and coordination of the spine and pelvis using principles of motor learning such as segmentation and simplification. The whole intervention is based on assessment of the individual patient's motor control impairments and the patient's individual treatment goals (set collaboratively with the therapist).
Graded activity	Graded activity	A primary goal of the graded activity program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. The intervention uses cognitive behavioral approaches to deal with fear of movement and self efficacy.

Primary Outcome Measures

Name	Time	Method
Patient Specific Functional Scale	12 months	This scale evaluates patient's self function on a scale from 0-10.

Secondary Outcome Measures

Name	Time	Method
SF-36	2, 6 and 12 months	The SF-36 will be used to assess self reported quality of life
Numeric Rating Scale- pain	2, 6 and 12 months	A numeric rating scale from 0-10 will be used to assess average level of pain over the last week
Patient Specific Functional Scale	2 and 6 month	This scale evaluates patient's self reported function on a scale from 0-10
Roland Morris Disability Questionnaire	2, 6 and 12 months	The RMDQ questionnaires evaluates pain related disability on a scale from 0-24.

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada