Feasibility of an Interprofessional Rehabilitation Program for Chronic Low Back Patients in the Ethiopian Health Setting
CompletedNot applicableNCT05866146
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The overall aim of this pilot RCT is to assess the feasibility of conducting a future definitive randomized control trial (RCT) for evaluating the effectiveness of an interprofessional rehabilitation program compared to the usual care in adults with chronic low back pain in Ethiopia. Specific objectives of this study include: * To evaluate the feasibility of trial procedures (recruitment rate, retention rate, adherence rate). * To explore the feasibility and acceptability of the intervention from the patients' and care providers' perspectives. * To estimate the preliminary treatment effect and standard deviation of the relevant clinical outcome measures (physical functioning, pain intensity, workability, HRQoL, global rating of changes) in people with CLBP to inform sample size calculation for the definitive RCT. People with chronic low back pain diagnosed through focused history and physical examination are accepted for enrolment. Each eligible patient will have an equal chance to be allocated to the intervention or control group. Participants of the intervention group will receive interprofessional rehabilitation for four weeks. Participants of the intervention group will receive interprofessional rehabilitation that contain components aimed at enabling optimal physical, psychological, and social functioning, including addressing the work abilities of patients. The components will include a comprehensive assessment, intensified physical activities and exercises, pain education, psychological support, occupational therapy, ergonomic interventions, and vocational counselling. Participants in the comparison group will receive the usual care according to the current standard care for patients with chronic low back pain at the University of Gondar specialized referral hospital in Ethiopia for over four weeks.
Study details
- Official title
- A Pilot Randomized Control Trial to Test the Feasibility of Evaluating the Effectiveness of an Interprofessional Rehabilitation Program for Patients With Chronic Low Back Pain in Ethiopia: A Study Protocol
- Conditions
- Interventions
- Other: Interprofessional rehabilitation program
- Other: Usual standard care
- Sponsor
- Sintayehu Wami
- Collaborators
- MasterCard Foundation Scholarship Program
- Organization
- Queen's University
- Start date
- 2023-04-11
- Primary completion
- 2023-09-22
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- Ethiopia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adults above the age of 18 years * Patients with chronic low back pain ('pain and discomfort localized below the costal margin and above the inferior gluteal folds, with or without leg pain') that persists for 3 months or more will be included in this trial Exclusion Criteria: * Patients who have serious known spinal pathology (e.g., tumours, vertebral fractures, and inflammatory diseases), and spinal surgery within the last 12 months will be excluded. * Participants with CLBP due to specific pathologies (e.g., infections, neoplasms, metastases, fractures, osteoporosis, rheumatoid arthritis, radiculopathies) or other inflammatory articular conditions (for example, ankylosing spondylitis), spinal stenosis, or fracture will also be excluded from the study
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05866146