Patient Education and Motor Control Exercise Among Rural Community-dwelling Adults With Chronic Low Back Pain

NCT03393104 | Completed

• 1 other identifier: SPS/15/PPT/00009
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low- and middle-income countries like those situated in Africa where most people are living in rural areas with limited access to health care. Epidemiological studies in Nigeria suggest that the burden of chronic low back pain (CLBP) in rural areas is greater than in urban areas, with both biomechanical and psychological factors being implicated. However, despite the burden of CLBP in rural Nigeria, rehabilitation services are lacking even at the rural primary healthcare centers due to the absence of physiotherapists. Current clinical practice guidelines unanimously recommend education including instruction on self-management options, and exercise as frontline interventions to help individuals with CLBP. However, the specific content of these interventions are rarely described. Patient education (PE) strategies incorporating both biomedical and psychosocial information have been shown to be beneficial for CLBP. Moreover, exercises in the form of motor control exercises (MCEs) have been proven to be effective for CLBP. However, RCTs examining the effects of PE and MCE individually or in combination among rural community-dwelling adults with CLBP are scarce. The purpose of this study is to determine the effects of PE and MCE program on selected clinical and psychosocial variables among rural community-dwelling adults with nonspecific CLBP.

Conditions

Nonspecific Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Motor Control Exercise; Patient Education

Outcome Measures

Primary Outcomes (2)

• 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, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up

• Change in pain Intensity

  Pain Intensity will be measured by an 11-point (0-10) Numerical Pain Rating Scale (NPRS), in which 0 represents "no pain" and 10 represents "worst pain imaginable".

  Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up

Secondary Outcomes (8)

• Change in quality of life

  Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up

• Change in global impression of recovery

  Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up

• Change in fear-avoidance beliefs

  Baseline, 8 weeks after beginning treatment, and 3-month follow-up

• Change in pain catastrophization

  Baseline, 8 weeks after beginning treatment, and 3-month follow-up

• Change in back pain consequences beliefs

  Baseline, 8 weeks after beginning treatment, and 3-month follow-up

Study Arms (3)

Motor Control Exercise and Patient Education

EXPERIMENTAL

Participants will receive a total of 16 sessions (2 sessions per week) of motor control exercise and 4 sessions (1 session per week) of patient education program as described in respective protocol. In addition, they will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group.

Behavioral: Motor Control Exercise; Behavioral: Patient Education

Motor Control Exercise

EXPERIMENTAL

Participants will receive a total of 16 sessions (2 sessions per week) of motor control exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement. They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group.

Behavioral: Motor Control Exercise

Patient Education

EXPERIMENTAL

Participants will receive patient education session once a week at interval of 1-week over 8-weeks (4 sessions). The program will be aiming to provide non-threatening information to enable patients to better understand their pain, change any unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies. They will also perform segmental stretching exercises and instructed to perform continuous overground walk as indicated in the control group.

Behavioral: Patient Education

Interventions

Motor Control Exercise BEHAVIORAL

Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.

Also known as: Specific stabilisation exercise

Motor Control Exercise; Motor Control Exercise and Patient Education

Patient Education BEHAVIORAL

Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.

Also known as: Cognitive Education

Motor Control Exercise and Patient Education; Patient Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female between 16 and 70 years old.
• Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
• Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
• 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.

Sponsors & Collaborators

• Bayero University Kano, Nigeria: lead

Study Sites (1)

Tsakuwa Primary Healthcare Center

Kano, 700, Nigeria

Location

Related Publications (2)

• Ibrahim AA, Akindele MO, Ganiyu SO. Effectiveness of patient education plus motor control exercise versus patient education alone versus motor control exercise alone for rural community-dwelling adults with chronic low back pain: a randomised clinical trial. BMC Musculoskelet Disord. 2023 Feb 23;24(1):142. doi: 10.1186/s12891-022-06108-9.

  PMID: 36823567 DERIVED

• Ibrahim AA, Akindele MO, Ganiyu SO, Bello B. Effects of motor control exercise and patient education program in the management of chronic low back pain among community-dwelling adults in rural Nigeria: a study protocol for a randomized clinical trial. Integr Med Res. 2019 Jun;8(2):71-81. doi: 10.1016/j.imr.2019.02.001. Epub 2019 Feb 21.

  PMID: 31080731 DERIVED

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Aminu A. Ibrahim

  Physiotherapy Department, Faculty of Allied Health Sciences, College of 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: December 6, 2017
• First Posted: January 8, 2018
• Study Start: March 3, 2018
• Primary Completion: October 1, 2019
• Study Completion: January 6, 2020
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

NG (1)