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

Nonspecific Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393104
• Other study ID #: SPS/15/PPT/00009
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: January 6, 2020

Study information

• Verified date: August 2021
• Source: Bayero University Kano, Nigeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 6, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Nonspecific Chronic Low Back Pain

Intervention

Behavioral:
• Motor Control Exercise
Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.
• 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.

Locations

Country	Name	City	State
Nigeria	Tsakuwa Primary Healthcare Center	Kano

Sponsors (1)

Lead Sponsor	Collaborator
Bayero University Kano, Nigeria

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional disability	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.	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Primary	Change in pain Intensity	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".	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary	Change in quality of life	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.	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary	Change in global impression of recovery	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.	Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up
Secondary	Change in fear-avoidance beliefs	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.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Secondary	Change in pain catastrophization	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.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Secondary	Change in back pain consequences beliefs	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.	Baseline, 8 weeks after beginning treatment, and 3-month follow-up
Secondary	Change in mobility of the spine and pelvis	The finger-floor distance test (FFD) measures mobility of both the whole spine and the pelvis in the overall motion of bending forward.	Baseline and 8 weeks after beginning treatment
Secondary	Change in functional performance of sit-to-stand	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.	Baseline and 8 weeks after beginning treatment
Secondary	Change in functional performance of 50-foot walk	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.	Baseline and 8 weeks after beginning treatment