A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
Recruitment status was: Recruiting
The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average intensity of pain, and worst intensity of pain. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (> 3 months) limb amputation.
The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.
Device: mirror-box treatment
Behavioral: Mental visualization
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain|
- Significant decrease in the level of phantom limb pain at 4 weeks.
- Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
|Study Start Date:||March 2006|
|Estimated Study Completion Date:||June 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301444
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307|
|Principal Investigator:||Jack W Tsao, MD||Walter Reed Army Medical Center|