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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment fidelity
研究概览
简要总结
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.
详细描述
Chronic low back pain (CLBP) is the most common type of musculoskeletal pain, and it has a substantial negative consequence on the ability to engage in meaningful activities, participation in work, health-related quality of life, and social relationships. CLBP-related disability is increasing worldwide, and the majority of this increase is associated with the growing burden in low-and-middle-income countries, including Ethiopia.
A growing body of evidence from high-income countries indicates the effectiveness of interprofessional rehabilitation programs for patients with CLBP. The currently implemented biomedically focused fragmented care in low- and middle-income countries appears to have limited lasting effect, owing to long-term disability. Therefore, this pilot RCT aims to evaluate the feasibility of conducting a definitive RCT to assess the effectiveness of an interprofessional rehabilitation program compared to the usual care for patients with CLBP in Ethiopia. Accordingly, the investigators will evaluate some elements of full RCT, including recruitment and retention rate, adherence, acceptability of the intervention, sample size estimation, and participants' preliminary responses to the interventions. Hence, this study will substantially benefit in informing components of the main trial design, minimizing uncertainties, and increasing the likelihood of successfully conducting the definitive RCT in the future. In addition, this pilot RCT is expected to provide a source of evidence for other initiatives aimed at developing and implementing interprofessional rehabilitation programs in a similar context.
A two-arm parallel single-blinded pilot randomized control trial (RCT), with embedded qualitative interviews, will be employed to assess the feasibility of conducting a full RCT to evaluate the effectiveness of an interprofessional rehabilitation program compared to the usual care in patients with CLBP.
Sample size: The investigators will recruit a total of 40 (i.e., 20 in the intervention group and 20 in the control group) patients with CLBP.
A simple block randomization method with random block sizes of 4 to 8 will be employed to randomize participants into the intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
In this study, research staff collecting outcome data from patients will be blinded to the group allocation. However, the treating health professionals and patients will not be blinded to group allocation due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Interprofessional rehabilitation program
Participants of the intervention group will receive an interprofessional rehabilitation program, which involve a combination of physical, psychological, behavioral, and/or vocational components, for four weeks.
干预措施: Interprofessional rehabilitation program (Other)
Usual standard care
The control group participants will receive the usual standard care according to the current practices at the University of Gondar specialized hospital over the same four weeks.
干预措施: Usual standard care (Other)
结局指标
主要结局
Treatment fidelity
时间窗: The data will be collected through intervention completion, up to five weeks.
The investigators will evaluate whether the intervention is delivered with fidelity according to the developed protocol. The care providers will assess and rate using a treatment fidelity checklist at each visit to evaluate treatment fidelity. Fidelity will be judged acceptable if the score is \> 75% compatible with the intervention protocol.
Patient recruitment rate
时间窗: The data will be collected at the baseline before the start of the intervention.
The recruitment rate is described as the number of eligible patients with CLBP recruited and randomized within two to three months at the University of Gondar specialized hospital. Hence, the recruitment rate will be calculated by dividing the total number of patients with CLBP recruited at the University of Gondar specialized hospital by the total recruitment period (number of months).
Acceptability of intervention and trial procedures
时间窗: The data will be collected through intervention completion, up to five weeks.
A qualitative description approach will be employed to explore the acceptability of the intervention and trial procedures from both treating health professionals and study participants' perspectives through an in-depth interview using a semi-structured interview guide. intervention from the patients' and care providers perspectives.
Patient retention rate
时间窗: The data will be collected through intervention completion, up to five weeks.
The number of patients recruited, randomized, and considered for the analysis will be used to calculate the retention rate. The retention rate will be calculated as the percentage of participants that complete all secondary outcome measures.
Intervention adherence rate
时间窗: The data will be collected through intervention completion, up to five weeks.
The intervention adherence rate will be determined by calculating the proportion of group and individual intervention sessions completed by the study participants as per the stated intervention protocol.
次要结局
- Self-efficacy(At baseline before the start of the intervention, and week 5/post-intervention)
- Global rating of change(week 5/post-intervention)
- Physical functioning(At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).)
- Pain intensity(At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).)
- Health-related quality of life(At baseline before the start of the intervention, the 5th week , and the 17th week (after 12 weeks of intervention completion).)
研究者
Sintayehu Wami
Principal investigator
Queen's University