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

NCT ID: NCT03398174

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-20

Study Completion Date

2018-05-01

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be blinded to participants' treatment allocation

Study Groups

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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.

Group Type EXPERIMENTAL

Motor Control Exercise

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Motor Control Exercise

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Patient Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Specific Stabilisation Exercise Psychosocial Education

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayero University Kano, Nigeria

OTHER

Sponsor Role lead

Responsible Party

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Aminu A. Ibrahim

Doctoral Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aminu A Ibrahim, BPT, MPT

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria

Locations

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Tsakuwa Primary Healthcare Center

Kano, , Nigeria

Site Status

Countries

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Nigeria

References

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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.

Reference Type DERIVED
PMID: 30443533 (View on PubMed)

Other Identifiers

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SPS/PPT/15/00009

Identifier Type: -

Identifier Source: org_study_id

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