Clinical Trial: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Short Term Effect of Post Surgical Treatment of Mirror Therapy of Phantom Limb Pain

Brief Summary: 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.

Detailed Summary:

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

Sponsor: Ruhr University of Bochum

Current Primary Outcome: Current pain intensity [ Time Frame: after 14 treatment sessions ]

Current Pain intensity assessed by the Numeric Rating Scale (0-10)


Original Primary Outcome: Same as current

Current Secondary Outcome: Frequence of pain attacks [ Time Frame: after 14 treatment sessions ]

Total number of phantom limb pain attacks per day is documented


Original Secondary Outcome: Same as current

Information By: Ruhr University of Bochum

Dates:
Date Received: July 30, 2013
Date Started: April 2013
Date Completion: March 2014
Last Updated: July 30, 2013
Last Verified: April 2012