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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Motor Control Exercise
Patient Education
Sponsored by
Bayero University Kano, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Rural dwellers, Patient Education, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tsakuwa Primary Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Motor Control Exercise Plus Patient Education

Motor Control Exercise

Patient Education

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
January 6, 2018
Last Updated
November 13, 2018
Sponsor
Bayero University Kano, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT03398174
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Rural dwellers, Patient Education, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to participants' treatment allocation
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Control Exercise Plus Patient Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Motor Control Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor Control Exercise
Other Intervention Name(s)
Specific Stabilisation Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Other Intervention Name(s)
Psychosocial Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain Intensity
Description
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.
Title
Change in functional disability
Description
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.
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminu A Ibrahim, BPT, MPT
Organizational Affiliation
Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tsakuwa Primary Healthcare Center
City
Kano
ZIP/Postal Code
700
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30443533
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.
Results Reference
derived

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

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