NCT03398174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

January 6, 2018

Last Update Submit

November 13, 2018

Conditions

Chronic Low Back Pain

Keywords

Rural dwellersPatient EducationExercise

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • Patient satisfaction

    6 weeks after beginning treatment.

Study Arms (3)

Motor Control Exercise Plus Patient Education

EXPERIMENTAL

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 ExerciseBehavioral: Patient Education

Motor Control Exercise

EXPERIMENTAL

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

Patient Education

EXPERIMENTAL

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

Interventions

Motor Control ExerciseBEHAVIORAL

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.

Also known as: Specific Stabilisation Exercise
Motor Control ExerciseMotor Control Exercise Plus Patient Education
Patient EducationBEHAVIORAL

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.

Also known as: Psychosocial Education
Motor Control Exercise Plus Patient EducationPatient Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsakuwa Primary Healthcare Center

Kano, 700, Nigeria

Location

Related Publications (1)

  • 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.

    PMID: 30443533DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Aminu A Ibrahim, BPT, MPT

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to participants' treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

January 6, 2018

First Posted

January 12, 2018

Study Start

January 20, 2018

Primary Completion

April 30, 2018

Study Completion

May 1, 2018

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

NG(1)