Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 37 of 1345 for:    rural

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398174
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Aminu A. Ibrahim, Bayero University Kano, Nigeria

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Behavioral: Motor Control Exercise Behavioral: Patient Education Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors will be blinded to participants' treatment allocation
Primary Purpose: Treatment
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.
Actual Study Start Date : January 20, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Motor Control Exercise Plus Patient Education

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.

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.

Other Name: Specific Stabilisation Exercise

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.

Other Name: Psychosocial Education

Experimental: Motor Control Exercise

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.

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.

Other Name: Specific Stabilisation Exercise

Experimental: Patient Education

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.

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.

Other Name: Psychosocial Education




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 6 weeks after beginning treatment. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398174


Locations
Layout table for location information
Nigeria
Tsakuwa Primary Healthcare Center
Kano, Nigeria, 700
Sponsors and Collaborators
Bayero University Kano, Nigeria
Investigators
Layout table for investigator information
Principal Investigator: Aminu A Ibrahim, BPT, MPT Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Aminu A. Ibrahim, Doctoral Student, Bayero University Kano, Nigeria
ClinicalTrials.gov Identifier: NCT03398174     History of Changes
Other Study ID Numbers: SPS/PPT/15/00009
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aminu A. Ibrahim, Bayero University Kano, Nigeria:
Rural dwellers
Patient Education
Exercise
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms