Phantom Limb Pain Clinical Trial
Official title:
Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain
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.
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
- pain intensity (11 point NRS, phantom limb in-tensity)
- pain frequency (amount of pain attacks) Secondary objectives
- diary
- daily assessment of mirror and physical thera-py sessions
- analysis:
- in significant differences between the groups a covariance analysis will be performed
- comparison of medians
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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