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

Sponsor
Bayero University Kano, Nigeria (Other)
Overall Status
Completed
CT.gov ID
NCT03393104
Collaborator
(none)
120
1
3
22.1
5.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Motor Control Exercise
  • Behavioral: Patient Education
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be blinded to participants' treatment allocation.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 3, 2018
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Jan 6, 2020

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Change in functional disability [Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up]

      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.

    2. Change in pain Intensity [Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up]

      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

    1. Change in quality of life [Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up]

      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.

    2. Change in global impression of recovery [Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up]

      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.

    3. Change in fear-avoidance beliefs [Baseline, 8 weeks after beginning treatment, and 3-month follow-up]

      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.

    4. Change in pain catastrophization [Baseline, 8 weeks after beginning treatment, and 3-month follow-up]

      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.

    5. Change in back pain consequences beliefs [Baseline, 8 weeks after beginning treatment, and 3-month follow-up]

      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.

    6. Change in mobility of the spine and pelvis [Baseline and 8 weeks after beginning treatment]

      The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.

    7. Change in functional performance of sit-to-stand [Baseline and 8 weeks after beginning treatment]

      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.

    8. Change in functional performance of 50-foot walk [Baseline and 8 weeks after beginning treatment]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tsakuwa Primary Healthcare Center Kano Nigeria 700

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aminu A. Ibrahim, Doctoral Student, Bayero University Kano, Nigeria
    ClinicalTrials.gov Identifier:
    NCT03393104
    Other Study ID Numbers:
    • SPS/15/PPT/00009
    First Posted:
    Jan 8, 2018
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aminu A. Ibrahim, Doctoral Student, Bayero University Kano, Nigeria
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 20, 2021