Clinical trial NCT03393104: 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
Overall status: COMPLETED
Phase: NA
Conditions: Nonspecific Chronic Low Back Pain
Keywords: Chronic Low Back Pain
Motor Control Exercise
Patient Education
Lead sponsor: Bayero University Kano, Nigeria
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in functional disability
timeFrame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
measure: Change in pain Intensity
timeFrame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary outcomes:
measure: Change in quality of life
timeFrame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
measure: Change in global impression of recovery
timeFrame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
measure: Change in fear-avoidance beliefs
timeFrame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
measure: Change in pain catastrophization
timeFrame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
measure: Change in back pain consequences beliefs
timeFrame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up
measure: Change in mobility of the spine and pelvis
timeFrame: Baseline and 8 weeks after beginning treatment
measure: Change in functional performance of sit-to-stand
timeFrame: Baseline and 8 weeks after beginning treatment
measure: Change in functional performance of 50-foot walk
timeFrame: Baseline and 8 weeks after beginning treatment
Other outcomes:
Locations:
city: Kano
country: Nigeria
facility: Tsakuwa Primary Healthcare Center
Study officials:
affiliation: Physiotherapy Department, Faculty of Allied Health Sciences, College of Health Sciences, Bayero University, Kano. Nigeria
name: Aminu A. Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
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.