A Pilot Study of Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in Rural Nigerian Community.

Study Overview
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Brief Summary
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The main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (CLBP) in a low resource rural Nigerian community.

Detailed Description
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This study will determine whether supervised exercise training emphasizing motor control exercise (MCE) approach and a designed patient education (PE) program based on the psychosocial approach will be feasible and acceptable in reducing pain intensity and functional disability among rural dwellers with CLBP in Nigeria. Participants will be recruited and assigned to one of three intervention groups that include MCE group, PE group, or MCE plus PE gr using a simple random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all clinical outcomes will be performed at baseline and 6 weeks after randomization. Primary outcomes include pain intensity and functional disability while secondary outcomes include overall treatment satisfaction. Data will be analyzed using descriptive statistics, paired t-test, and ANOVA. All statistical analyses will be performed on SPSS (version 24.00) at an alpha level of 0.05.

Official Title
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Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in a Low-Resource Rural Nigerian Community: A Pilot Randomized Controlled Trial.

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Motor Control Exercise
* Behavioral: Patient Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female between 18 and 65 years old. Primary complaint of LBP experienced at least over the previous 3-month duration. Ability to read/understand English or Hausa language. Exclusion Criteria: Previous history of thoracic spine or lumbosacral spine surgery. Any neurological findings indicating radiculopathy. Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease). Unstable or severe disabling chronic cardiovascular and pulmonary disease. History of serious psychological or psychiatric illness. Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motor Control Exercise Plus Patient Education<br>Participants will receive a total of 12 sessions (2 sessions per week) of exercise program consisting of motor control training and group patient education session once a week (6 sessions) all over 6-weeks. The motor control training will be aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. The patient education program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. | Behavioral: Motor Control Exercise<br>* Exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.<br>* Other names: Specific Stabilisation Exercise;Behavioral: Patient Education<br>* Patient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.<br>* Other names: Psychosocial Education;|
| Experimental: Motor Control Exercise<br>Participants will receive the same motor control exercise program described in the patient education and motor control exercise group. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. | Behavioral: Motor Control Exercise<br>* Exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.<br>* Other names: Specific Stabilisation Exercise;|
| Experimental: Patient Education<br>Participants will receive the same patient education program described in the motor control exercise plus patient education group. In addition, participants will also perform stretching exercises and instructed to perform continuous overground walk. | Behavioral: Patient Education<br>* Patient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought. In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home.<br>* Other names: Psychosocial Education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain Intensity | Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS). | Baseline and 6 weeks after beginning treatment. | 
| Change in functional disability | Functional disability will be measured by Oswestry disability index (ODI). The questionnaire consists of 10 items with each item having six statements. All scores are summed, then multiplied by two to obtain the index (range 0 to 100) with higher score indicating greater disability. | Baseline and 6 weeks after beginning treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Patient satisfaction with treatment will be assessed using a 5-point Likert scale ranging from very dissatisfied (0) to very satisfied (4), with higher scores reflecting greater satisfaction. | 6 weeks after beginning treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rural dwellers, Patient Education, Exercise