Development of a Pain Rehabilitation Program for Chronic Pain After SCI
Feasibility of a New Digital Pain Rehabilitation Program for People With SCI
Pain rehabilitation programs are essential for optimal treatment of chronic pain and are usually based on the biopsychosocial model. This is, however, not standard care for people with chronic pain after a spinal cord injury (SCI) due to a biomedical focused perspective of SCI and lack of adapted programs.
The aims of this feasibility study:
- Develop a new digital pain rehabilitation program, adapted for the needs of people living with an SCI.
- To investigate the feasibility and acceptability of a new digital pain rehabilitation program.
研究概览
详细说明
This study follows the guidelines of Medical Research Council for complex interventions and the proposed iterative feasibility process to improve and prepare the intervention for future testing in an RCT study. The research group will, toghether with a reference groups, develop a digital intervention porposal. The program will be a team-based, goal-oriented program for patients with spinal cord injury (SCI) and chronic pain.
In this study, eligible participants are included in an 8 week pain rehabilitation program. The program is developed through user-involvement i.e. together with clinicians (experienced in pain rehabilitation and/or SCI rehabilitation), stakeholders, researchers and individuals with SCI. The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
The participants will fill in self-assessed questionaries at baseline and after the finish of the program about their pain, sleep, mood and quality of life. After the program some of the participants will be asked to participate in semi-structured interviews about how they navigate and engage with different components of the program. The patients will be recruited during a rutine follow up at an SCI clinic.
Seven factors will be studied to assess the feasibility and acceptability of the program, based on set goals according to the Traffic Light method.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Gunilla Stenberg, Docent
- 电话号码:+46 90 7869895
- 邮箱:gunilla.stenberg@umu.se
研究联系人备份
- 姓名:Sofia Björkbacka, MSc
- 电话号码:0046907869349
- 邮箱:sofia.bjorkbacka@umu.se
学习地点
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Umeå、瑞典、90736
- Inst. Community Medicine and Rehabilitation
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- two years since injury
- Stable pain medication?
Exclusion Criteria:
- severe cognitive impairment
- Alcohol or drug abuse
- does not understand Swedish
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Spinal cord injury (SCI) and chronic pain
People with chronic pain after spinal cord injury
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8- week pain rehabilitation program.
The first meeting of the program is located at a hospital facility and thereafter they will meet at a digital platform.The program include education, home exercises and group meetings.
The program consists of 4 modules.
1. Physical exercise and ergonomics.
2. Structure and recovery.
3. Employment/occupation and social support.
4. ACT and coping.
Each module lasts for two weeks.
The program will include video material for education, home exercises and group discussions led by clinicians with long experience in pain rehabilitation and SCI.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment rate, number recruited per quarter
大体时间:At enrollment
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Continue=6 Solve=4 Stop=3
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At enrollment
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Number of participant with treatment-related advere events as assessed by...
大体时间:From enrollment to the end of tretment at 8 weeks
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From enrollment to the end of tretment at 8 weeks
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Participant retention- Completion rates
大体时间:The end of the 8- week program
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>75% continue, 50-75% Solve, <50% stop
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The end of the 8- week program
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Program Adherence
大体时间:The end of the 8-week program
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Continue >75%, solve 50-75%, stop <50%
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The end of the 8-week program
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Patients' self-perceived relevance, timing and mode of delivery
大体时间:>70% Continue, Solve 50-70%, Stop <50%
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Patient evaluation, satisfied patients
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>70% Continue, Solve 50-70%, Stop <50%
|
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Assessment procedure acceptance- Patient evaluations, proportions of completed questionnaires
大体时间:At the end of the 8-week program
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>80% continue, 50-80% solve, <50% stop
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At the end of the 8-week program
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Fidelity of delivery - Process evaluations
大体时间:End of the 8-week program
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End of the 8-week program
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2023-04232-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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