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Completed

NCT Number: NCT03393104

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

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.

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Key information

Conditions

Nonspecific Chronic Low Back Pain

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsakuwa Primary Healthcare Center

Kano, 700, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female between 16 and 70 years old.
  • Primary complaint of LBP with or without leg pain experienced at least over the previous 3 months duration.
  • Mean LBP intensity at least ≥ 3 on numerical rating scale during the past week.
  • Ability to read/understand English or Hausa language.

Exclusion criteria

  • Previous history of thoracic spine or lumbosacral spine surgery.
  • Any neurological findings indicating radiculopathy.
  • Evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease).
  • Unstable or severe disabling chronic cardiovascular and pulmonary disease.
  • History of serious psychological or psychiatric illness.
  • Current pregnancy.

Treatment and study plan

Motor Control Exercise

Behavioral

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

Other names: Specific stabilisation exercise

Patient education

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.

Other names: Cognitive Education

Primary outcomes

  1. Change in functional disability

    Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 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.

  2. Change in pain Intensity

    Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 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".

Secondary outcomes

  1. Change in quality of life

    Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 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 global impression of recovery

    Time frame: Baseline, 8 weeks after beginning treatment, and 3, 6 and 12 months follow-up

    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.

  3. Change in fear-avoidance beliefs

    Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up

    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.

  4. Change in pain catastrophization

    Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up

    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.

  5. Change in back pain consequences beliefs

    Time frame: Baseline, 8 weeks after beginning treatment, and 3-month follow-up

    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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Bayero University Kano, Nigeria

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 8, 2018
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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