Pain Coping Skills Training for Spinal Cord Stimulator Implant Candidates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Improvements in pain, psychological distress, and physical disability
研究概览
简要总结
This study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants.
The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training. These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information.
详细描述
This study tests the hypotheses that a pain coping skills program in combination with an SCS implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain, physical disability, psychological distress, and pain intensity.
Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial. After patients have been approved, they can be enrolled in this study. After completing a baseline evaluation, patients are randomized into (1)six individual pain coping skills training sessions(relaxations techniques, communication skills, goal setting), (2) six individual chronic pain education sessions (discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants, or (3) treatment as usual (no study intervention).
Participants are evaluated prior to or shortly after their surgery, at post treatment, at 6 month follow-up and at 12 month follow-up. All participants continue their routine medical care throughout the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •pending litigation
- •not approved for implant
研究组 & 干预措施
Coping Skills Training
Coping Skills Training in pain management
干预措施: Coping Skills Training (Behavioral)
Education
Chronic Pain Education
干预措施: Education (Behavioral)
Usual Care
Patients receive no study intervention, continue with usual medical care.
结局指标
主要结局
Improvements in pain, psychological distress, and physical disability
时间窗: Pre-intervention, post-intervention, 6 month, and 12 month follow-ups
Improvements in pain, psychological distress, and physical disability Pre-intervention, post-intervention, 6 month, and 12 month follow-ups
次要结局
- Patients will learn a repertoire of coping skills which can be applied to other challenges in life.(Pre-intervention, post intervention, 6 month, and 12 month follow-ups)