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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.

B

Bayero University Kano, Nigeria

Status

Completed

Conditions

Chronic Low Back Pain

Treatments

Behavioral: Motor Control Exercise
Behavioral: Patient Education

Study type

Interventional

Funder types

Other

Identifiers

NCT03398174
SPS/PPT/15/00009

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 3 patient groups

Motor Control Exercise Plus Patient Education
Experimental group
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.
Treatment:
Behavioral: Patient Education
Behavioral: Motor Control Exercise
Motor Control Exercise
Experimental group
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.
Treatment:
Behavioral: Motor Control Exercise
Patient Education
Experimental group
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.
Treatment:
Behavioral: Patient Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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