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Motor Control Exercise and Patient Education for Community-Dwelling Adults With Chronic Low Back Pain in Rural Nigeria

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ClinicalTrials.gov Identifier: NCT03393104
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Aminu A. Ibrahim, Bayero University Kano, Nigeria

Brief Summary:

Low back pain (LBP) is the leading cause of years lived with disability globally with increasing concern about its impact in low-income countries like those situated in Africa where most people are rural residents with limited access to health care. In Nigeria, the prevalence of LBP is on the increase and even higher than in other African countries. Moreover, rural dwellers seem to have a greater burden of LBP compared to urban dwellers but lack access to rehabilitation services such as physiotherapy even at the rural primary health care centres. While exercise and education are commonly recommended in the management of chronic LBP, with many trials using these interventions being conducted on urban dwellers, there is a dearth of community studies in the way of randomized clinical trials, testing the benefits of exercise and education in the management of chronic LBP among adults rural Nigerian community.

The purpose of this project is to assess the effect of a supervised exercise therapy that emphasize on motor control approach and a cognitive-based patient education for the management of chronic LBP among community-dwelling adults in a rural Nigeria.


Condition or disease Intervention/treatment Phase
Chronic Nonspecific Low Back Pain Behavioral: Motor Control Exercise Behavioral: Patient Education Not Applicable

Detailed Description:

The hypothesis of this study is that MCE plus PE will be superior in all outcomes than using either MCE or PE alone among adults with CLBP following 8-weeks of therapeutic session, at 3-month follow-up.

Participants will be recruited and assigned to one of four intervention groups that include MCE plus PE 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 clinical outcomes will be performed at baseline, 8 weeks after randomization and at 3 months follow up.

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


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Study Type : Interventional  (Clinical Trial)
Estimated 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 Motor Control Exercise and Patient Education for the Management of Chronic Low Back Pain Among Community-Dwelling Adults in Rural Nigeria: A Randomized Clinical Trial
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Cognitive Education




Primary Outcome Measures :
  1. Change in pain Intensity [ Time Frame: Baseline, 8 weeks after beginning treatment, and 3 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".

  2. Change in functional disability [ Time Frame: Baseline, 8 weeks after beginning treatment, and 3 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.


Secondary Outcome Measures :
  1. Change in quality of life [ Time Frame: Baseline, 8 weeks after beginning treatment, and 3 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 fear avoidance beliefs [ Time Frame: Baseline and 8 weeks after beginning treatment ]
    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.

  3. Change in pain catastrophization [ Time Frame: Baseline and 8 weeks after beginning treatment ]
    Pain catastrophization 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.

  4. Change in global impression of recovery [ Time Frame: Baseline and 8 weeks after beginning treatment. ]
    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.

  5. Change in mobility of the spine and pelvis [ Time Frame: 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.

  6. Change in functional performance of sit-to-stand [ Time Frame: 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.

  7. Change in functional performance of 50-foot walk [ Time Frame: 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.



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female between 16 and 70 years old.
  2. Primary complaint of LBP experienced at least over the previous 3 month duration.
  3. Mean LBP intensity at least ≥ 3 on numeric 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393104


Contacts
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Contact: Aminu A. Ibrahim, BPT, MPT +2348035579465 amenconafs@gmail.com
Contact: Dr. Akindele O. Mukadas, PhD +2348035537101 moakindele.pth@buk.edu.ng

Locations
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Nigeria
Tsakuwa Primary Healthcare Center Recruiting
Kano, Nigeria, 700
Contact: Aminu A. Ibrahim, BPT. MPT    +2348035579465    amenconafs@gmail.com   
Contact: Dr. Akindele O. Mukadas, PhD    +2348035537101    moakindele.pth@buk.edu.ng   
Sponsors and Collaborators
Bayero University Kano, Nigeria
Investigators
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Principal Investigator: Aminu A. Ibrahim Physiotherapy Department, Faculty of Allied Health Sciences, Bayero University, Kano. Nigeria

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aminu A. Ibrahim, Doctoral Student, Bayero University Kano, Nigeria
ClinicalTrials.gov Identifier: NCT03393104     History of Changes
Other Study ID Numbers: SPS/15/PPT/00009
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aminu A. Ibrahim, Bayero University Kano, Nigeria:
Chronic Low Back Pain
Motor Control Exercise
Patient Education
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms