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Clinical Trials/NCT03398174
NCT03398174
Completed
N/A

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.

Bayero University Kano, Nigeria1 site in 1 country30 target enrollmentJanuary 20, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Bayero University Kano, Nigeria
Enrollment
30
Locations
1
Primary Endpoint
Change in functional disability
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 20, 2018
End Date
May 1, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bayero University Kano, Nigeria
Responsible Party
Principal Investigator
Principal Investigator

Aminu A. Ibrahim

Doctoral Student

Bayero University Kano, Nigeria

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in functional disability

Time Frame: Baseline and 6 weeks after beginning treatment.

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.

Change in pain Intensity

Time Frame: Baseline and 6 weeks after beginning treatment.

Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS).

Secondary Outcomes

  • Patient satisfaction(6 weeks after beginning treatment.)

Study Sites (1)

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