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

Primary Purpose

Nonspecific Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Motor Control Exercise
Patient Education
Sponsored by
Bayero University Kano, Nigeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonspecific Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Motor Control Exercise, Patient Education

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tsakuwa Primary Healthcare Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Motor Control Exercise and Patient Education

Motor Control Exercise

Patient Education

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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".

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 6, 2017
Last Updated
August 14, 2021
Sponsor
Bayero University Kano, Nigeria
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1. Study Identification

Unique Protocol Identification Number
NCT03393104
Brief Title
Patient Education and Motor Control Exercise Among Rural Community-dwelling Adults With Chronic Low Back Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
January 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayero University Kano, Nigeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Motor Control Exercise, Patient Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blinded to participants' treatment allocation.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor Control Exercise and Patient Education
Arm Type
Experimental
Arm Description
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.
Arm Title
Motor Control Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Patient Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor Control Exercise
Other Intervention Name(s)
Specific stabilisation exercise
Intervention Description
Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Other Intervention Name(s)
Cognitive Education
Intervention Description
Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.
Primary Outcome Measure Information:
Title
Change in functional disability
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Title
Change in pain Intensity
Description
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".
Time Frame
Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary Outcome Measure Information:
Title
Change in quality of life
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Title
Change in global impression of recovery
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Title
Change in fear-avoidance beliefs
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Title
Change in pain catastrophization
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Title
Change in back pain consequences beliefs
Description
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.
Time Frame
Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Title
Change in mobility of the spine and pelvis
Description
The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.
Time Frame
Baseline and 8 weeks after beginning treatment
Title
Change in functional performance of sit-to-stand
Description
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.
Time Frame
Baseline and 8 weeks after beginning treatment
Title
Change in functional performance of 50-foot walk
Description
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.
Time Frame
Baseline and 8 weeks after beginning treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminu A. Ibrahim
Organizational Affiliation
Physiotherapy Department, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano. Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tsakuwa Primary Healthcare Center
City
Kano
ZIP/Postal Code
700
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31080731
Citation
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.
Results Reference
derived

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

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