A Randomized Controlled Trial of the Stanford Chronic Pain Self-Management Programme in Danish Chronic Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
研究概览
简要总结
The effect of the Stanford Chronic Pain Self-Management Programme (CPSMP) is tested in a randomized controlled trial with enrollment of Danish chronic pain patients. A total of 500 chronic pain patients is randomized into either an CPSMP intervention group or a control group.
The CPSMP is brief patient education program consisting of 6 weekly sessions. Two trained instructors teach a group of 8-16 chronic pain patients about managing pain. The instructors are not health professionals but chronic pain patient themselves. The program is highly structured and manualized.
Previous studies have shown beneficial effects of the CPSMP on pain, self-efficacy and well-being. Hence we expect the CPSMP to have an effect on various domains.
- Symptom reduction - lower self-reported pain in the CPSMP group compared to controls
- Illness perception - the cpsmp group will differ from controls in illness perception and have higher disease related self-efficacy
- Sickness behavior - the cpsmp group will have fewer sick days and lower health care utilization (estimated by registerbased data)than controls
- Quality of life - the cpsmp group will report higher life satisfaction and less social isolation than controls
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
- •Pain in more than 3 months
- •Self-reported pain > 4.99 on 10 point Likert scale
- •Age > 18 years old
- •Able to understand, speak, and read Danish
排除标准
- •Pain related to conditions that the patient are likely to consider more important than pain itself, e.g. pregnancy, cancer in acute phases
- •Drug abuse, psychiatric or physical disease that would prevent participation in weekly sessions
- •Drug abuse, psychiatric or physical disease that would disturb completion of group sessions
结局指标
主要结局
Decrease in score on the Roland-Morris Disability Questionnaire (Roland & Morris, 1983)
时间窗: 6 months follow-up
次要结局
- Increase in score on pain related self-efficacy questionnaire (Lorig et al., 1989)(6 months follow-up)
- Register-based data on visits to GP after intervention (Danish National Register of Health Care utilization)(6-months follow-up)
- Register-based data on use of prescribed drugs after intervention (Danish National Register of Health Care utilization)(6 months follow-up)