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

Effects of Patient Education and Motor Control Exercise on Selected Clinical and Psychosocial Variables Among Rural Community-dwelling Adults With Chronic Low Back Pain: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Nonspecific Chronic Low Back Pain
• Intervention / Treatment: Behavioral: Motor Control Exercise; Behavioral: Patient Education

Detailed Description

Participants will be recruited and assigned to one of three intervention groups that include PE plus MCE group, MCE group, or PE group using a block random technique based on an electronic randomization table generated by a computer software program. Blinded assessment of all outcomes will be performed at baseline, 8 weeks after randomization and at 3, 6 and 12 months follow-up.

Primary outcomes will be functional disability and pain intensity. Secondary outcomes will be quality of life, global perceived recovery, fear-avoidance beliefs, pain catastrophizing, back pain consequences beliefs, and physical performance (finger-floor test, repeated sit-to-stand test, and the 50-foot walk test) Data will be analyzed using descriptive and inferential (mixed-model ANOVA/linear mixed-effects model) statistics. All statistical analyses will be performed on IBM SPSS Statistics ver. 23.0 (IBM Co., Armonk, NY, USA) at alpha level of 0.05.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Kano, Nigeria, 700
    • Tsakuwa Primary Healthcare Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female between 16 and 70 years old.
2. Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
3. Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
4. Ability to read/understand English or Hausa language.

Exclusion Criteria:

1. Previous history of thoracic spine or lumbosacral spine surgery.
2. Any neurological findings indicating radiculopathy.
3. Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease).
4. Unstable or severe disabling chronic cardiovascular and pulmonary disease.
5. History of serious psychological or psychiatric illness.
6. Current pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motor Control Exercise and Patient Education; 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; Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.; Other Names: Specific stabilisation exercise; Behavioral: Patient Education; Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.; Other Names: Cognitive Education
Experimental: Motor Control Exercise; 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; Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.; Other Names: Specific stabilisation exercise
Experimental: Patient Education; 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; Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.; Other Names: Cognitive Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Quality of life will be measured using the SF-12 health survey. The questionnaire consists of 12 items questioned weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better health.	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in global impression of recovery	Global impression of recovery will be measured by an 11-point Global Perceived Effect Scale (GPES). it range from -5 (vastly worse) to 0 (unchanged) to +5 (completely recovered). Higher scores indicate better recovery.	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Change in fear-avoidance beliefs	Fear avoidance beliefs will be measured by the fear-avoidance beliefs questionnaire (FABQ). The questionnaire consists of 16 self-response items, rated on a seven-point ordinal scale from 0 to 6. It also contains two subscales, a 7-item subscale concerning work, and a 4-item subscale concerning physical activity. Each subscale scores are summed giving possible ranges for the physical activity subscale of 0-24 and for the work subscale between 0-42. Higher score indicate greater fear and avoidance beliefs.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in pain catastrophization	Pain catastrophizing will be measured by the pain catastrophizing scale (PCS). The scale consists of 13 items rated on 5-point ordinal scale (0-5).The total score ranges from 0-52 with higher score indicating more catastrophic thoughts.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in back pain consequences beliefs	The back pain consequences beliefs will be measured by the Back Beliefs Questionnaire (BBQ). The BBQ is a 14-item scale, with each item rated using a 5-point Likert scale. Nine items (1, 2, 3, 6, 8, 10, 12, 13, and 14) are used for scoring of the questionnaire resulting in a total score ranging from 9-45 with lower scores indicating the more pessimistic beliefs regarding the consequences of back pain.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Change in mobility of the spine and pelvis	The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.	Baseline and 8 weeks after beginning treatment
Change in functional performance of sit-to-stand	The repeated sit-to-stand test measures the time taken to sit-to-stand, five times from a standard chair. The shorter the time taken to complete the test, the better the performance.	Baseline and 8 weeks after beginning treatment
Change in functional performance of 50-foot walk	The 50-foot walk test measures time taken to walk a distance of 50-foot. The shorter the time taken to complete the test, the better the performance.	Baseline and 8 weeks after beginning treatment

Collaborators and Investigators

• Sponsor: Bayero University Kano, Nigeria
• Investigators: Principal Investigator: Aminu A. Ibrahim, Physiotherapy Department, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano. Nigeria

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): January 6, 2020

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: January 5, 2018
• First Posted (Actual): January 8, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Low Back Pain; Patient Education; Motor Control Exercise
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: SPS/15/PPT/00009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No