Clinical trial NCT03398174: A Pilot Study of Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain in Rural Nigerian Community.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Rural dwellers
Patient Education
Exercise
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain Intensity
timeFrame: Baseline and 6 weeks after beginning treatment.
measure: Change in functional disability
timeFrame: Baseline and 6 weeks after beginning treatment.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks after beginning treatment.
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Tsakuwa Primary Healthcare Center
Study officials:
affiliation: Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria
name: Aminu A Ibrahim, BPT, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ibrahim AA, Akindele MO, Ganiyu SO. Motor control exercise and patient education program for low resource rural community dwelling adults with chronic low back pain: a pilot randomized clinical trial. J Exerc Rehabil. 2018 Oct 31;14(5):851-863. doi: 10.12965/jer.1836348.174. eCollection 2018 Oct.