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

Chronic Low Back Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03398174
• Other study ID #: SPS/PPT/15/00009
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: May 1, 2018

Study information

• Verified date: November 2018
• Source: Bayero University Kano, Nigeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Nigeria	Tsakuwa Primary Healthcare Center	Kano

Sponsors (1)

Lead Sponsor	Collaborator
Bayero University Kano, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.