Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Current pain intensity
研究概览
简要总结
The aim of the study is the measurement of the short term effect of post surgical mirror therapy concerning pain intensity and frequency of patients with upper or lower amputation in comparison to standard occupational or physical therapy. The hypothesis is that patients in the intervention group (mirror therapy) suffer significantly less from phantom limb pain and pain attacks within a follow-up period of 4-8 weeks.
详细描述
Aim:
- Measurement of the short term effect of post surgical/ post-operative mirror therapy concerning pain intensity of patients with upper or lower amputation in comparison to standard occupational/ physical therapy
- Hypothesis: patients in the intervention group (mirror therapy) suffer from significant less phantom limb pain and a lower pain frequency within a follow-up period of 4-8 weeks
Methods:
- Design: multicenter, prospective, randomized controlled trial
- Participants: 70, 35 per intervention and con-trol group
- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
- Control group: receive treatment session of 60 minutes with the same treatment frequency over a period of 14 days
- Measurement tools:
Primary objectives
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major amputation of lower and upper body
- •phantom pain, or pain attacks in combination with a treatment wish
- •age of 18 years
- •signed informed consent
- •linguistic and cognitive comprehension
排除标准
- •bilateral amputation
- •major neurologic comorbidities (stroke, Parkinson disease)
- •morbidities of the contralateral side with functional limitations
- •experience with long term standardised mirror therapy
- •internal comorbidities (pAVK)
- •psychological comorbidities
研究组 & 干预措施
Mirror therapy
60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
干预措施: Occupational/ physical therapy (Other)
Mirror therapy
60 minutes of mirror therapy each day over a period of 14 days starting directly post surgically (24-48 hours after surgery)
干预措施: Mirror therapy (Other)
Occupational/ physical therapy
60 minutes of occupational/ physical therapy each day over a period of 14 days starting 24-48 hours post surgically
干预措施: Occupational/ physical therapy (Other)
结局指标
主要结局
Current pain intensity
时间窗: after 14 treatment sessions
Current Pain intensity assessed by the Numeric Rating Scale (0-10)
次要结局
- Frequence of pain attacks(after 14 treatment sessions)
研究者
Christoph Maier, Prof. Dr.
Prof. Dr. Christoph Maier
Ruhr University of Bochum