Trials / Completed
CompletedNCT03398174
A Pilot Study of Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in Rural Nigerian Community.
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.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Bayero University Kano, Nigeria · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Motor Control Exercise | 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. |
| BEHAVIORAL | Patient Education | 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. |
Timeline
- Start date
- 2018-01-20
- Primary completion
- 2018-04-30
- Completion
- 2018-05-01
- First posted
- 2018-01-12
- Last updated
- 2018-11-15
Locations
1 site across 1 country: Nigeria
Source: ClinicalTrials.gov record NCT03398174. Inclusion in this directory is not an endorsement.