Optimization of a Chronic Pain Self-management Program - a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Pain-related functional limitations
研究概览
简要总结
The goal of this clinical trial is to compare two different modes of delivering a self-management program for chronic pain (independently vs. with additional support) on pain-related disability.
Participants with chronic musculoskeletal pain will take part in a 10-week online pain self-management program. For the participants in the group with additional support, the intervention will also include two physiotherapist-led sessions and one group session with other participants.
The hypothesis is that the results will support that both modes of delivery could be effective, but the self-management program with additional support will be more effective for reducing pain intensity and pain disability compared to the self-management program alone.
详细描述
The primary objective of this pilot randomized controlled trial (RCT) is to compare the short-, mid-, and long-term effects (10 and 26 weeks following the start of the intervention) of two different modes of delivering a self-management program for chronic pain (self-management vs. enhanced self-management, offering two physiotherapist-led and one patient-partner-led sessions) on pain-related disability in a group of patients with chronic musculoskeletal (MSK) pain. Secondary objectives include comparing the effects of the two delivery modes on pain severity and on psychological constructs related to pain, namely kinesiophobia, catastrophizing, pain self-efficacy, anxiety, and depression.
The hypothesis is that the results will support both modes of delivery, but that the enhanced self-management program will lead to larger effects on pain-related disability and pain intensity.
Methodology Participants: 86 adults (aged between 18 and 75) with chronic MSK pain (>3 months) will be included. Potential participants will be recruited from waiting lists of pain-management programs and through email lists and social media.
Study design: This parallel group RCT will include three evaluation sessions over six months (baseline, 10 and 26 weeks) and, for the enhanced self-management group, three in-person meetings over 10 weeks. Questionnaires will be completed online using the REDCap web application. At baseline, participants will first complete a questionnaire on sociodemographic, symptomatology and comorbidity. Self-administered questionnaires for assessing primary and secondary outcomes will be completed by participants at all evaluation sessions. A global rating of change question will also be completed at 10 and 26 weeks. For the enhanced self-management group, the in-person meetings will be carried out at Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris). Ethics approval has been obtained from the sectorial rehabilitation and social integration research ethics committee of the CIUSSS-CN (project #2024-2935).
Randomisation/blinding: A randomisation list has established prior to the beginning of the study using a random number generator. An independent research assistant not involved in data collection generated the randomisation list. Randomisation is stratified to ensure balance of the treatment groups with respect to self-reported gender (3 categories : man, woman, and all other gender identities). A blocked randomisation was used to make sure that two equal groups of 43 participants will be obtained. Participants will be unaware of the intervention delivery mode received by the other group.
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
Outcome assessment is masked as all outcomes are derived from self-administered questionnaires that will be filled online without the presence of any member of the research team.
Data analysis will be masked (intervention groups will be coded).
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having musculoskeletal pain for more than 3 months.
排除标准
- •Unable to participate throughout the 26 weeks of the study.
- •Having a diagnosis of rheumatoid, inflammatory or neurodegenerative diseases, fibromyalgia or of complex regional pain syndrome.
- •Having received a corticosteroid injection in the previous twelve weeks.
结局指标
主要结局
Pain-related functional limitations
时间窗: Change from baseline at 10 weeks, change from baseline at 26 weeks
The Pain Interference subscale from the short-form of the Brief Pain Inventory questionnaire (BPI-SF). Calculated as the mean of the seven interferences items of the BPI-SF, with a score ranging from 0 (does not interfere) to 10 (completely interferes).
次要结局
- Pain Severity(Change from baseline at 10 weeks, change from baseline at 26 weeks)
- Pain catastrophizing(Change from baseline at 10 weeks, change from baseline at 26 weeks)
- Kinesiophobia(Change from baseline at 10 weeks, change from baseline at 26 weeks)
- Pain-related Self-Efficacy(Change from baseline at 10 weeks, change from baseline at 26 weeks)
- Patient satisfaction with intervention(At 10 weeks (end of intervention period))
- Anxiety and Depression(Change from baseline at 10 weeks, change from baseline at 26 weeks)
- Patient Acceptable Symptom State (PASS)(At baseline, 10 weeks, and 26 weeks)
- Global condition change since start of intervention, assessed by a global rating of change question(At 10 weeks and 26 weeks)
研究者
Jean-Sébastien Roy
Professor
Laval University