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

NCT ID: NCT03393104

Last Updated: 2021-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-03
• Study Completion Date: 2020-01-06

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.

Conditions

Nonspecific Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Motor Control Exercise

Intervention Type: BEHAVIORAL

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

Patient Education

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Motor Control Exercise

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Patient Education

Intervention Type: 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.

Interventions

Motor Control Exercise

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Specific stabilisation exercise; Cognitive Education

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayero University Kano, Nigeria

OTHER

Sponsor Role: lead

Responsible Party

Aminu A. Ibrahim

Doctoral Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aminu A. Ibrahim

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano. Nigeria

Locations

Tsakuwa Primary Healthcare Center

Kano, , Nigeria

Countries

Nigeria

References

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.

Reference Type: DERIVED

PMID: 36823567 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31080731 (View on PubMed)

Other Identifiers

SPS/15/PPT/00009

Identifier Type: -

Identifier Source: org_study_id