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

Bayero University Kano, Nigeria

Status: Completed

Conditions: Nonspecific Chronic Low Back Pain

Treatments: Behavioral: Motor Control Exercise; Behavioral: Patient Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03393104

SPS/15/PPT/00009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Motor Control Exercise and Patient Education

Experimental group

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.

Treatment:

Behavioral: Patient Education

Behavioral: Motor Control Exercise

Motor Control Exercise

Experimental group

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.

Treatment:

Behavioral: Motor Control Exercise

Patient Education

Experimental group

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.

Treatment:

Behavioral: Patient Education