Skip to main content
OpenTrials
Completed

NCT Number: NCT03398174

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsakuwa Primary Healthcare Center

Kano, 700, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Motor Control Exercise

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.

Other names: Specific Stabilisation Exercise

Patient education

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.

Other names: Psychosocial Education

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayero University Kano, Nigeria

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2018
Registry last updated
Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.