An interventional study of Motor Control Exercise and Patient Education in Chronic Low Back Pain, sponsored by Bayero University Kano, Nigeria. Completed at 1 site in Nigeria. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by Bayero University Kano, Nigeria · Not applicable, Interventional, and Treatment
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.
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
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Exclusion Criteria:
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 · Behavioral: Patient Education
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
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
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.
Also known as: Specific Stabilisation Exercise
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.
Also known as: Psychosocial Education
Change in pain Intensity
Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS).
Time frame: 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.
Time frame: Baseline and 6 weeks after beginning treatment.
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.
Time frame: 6 weeks after beginning treatment.
Plan to share: Undecided
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Bayero University Kano, Nigeria