Which Exercise for Low Back Pain: A Validation Study

NCT ID: NCT03327753

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2018-12-31

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.

Conditions

Chronic Low Back Pain; Non Specific Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Motor control exercises

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Graded activity

Intervention Type: BEHAVIORAL

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.

Interventions

Motor control exercises

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.

Intervention Type: BEHAVIORAL

Graded activity

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Luciana Macedo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciana Macedo, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster University

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

WhichEx2017

Identifier Type: -

Identifier Source: org_study_id