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|
A total of forty-eight (48) subjects with be enrolled - twenty-four (24) with any unilateral lower limb amputation and twenty-four (24) with any unilateral upper limb amputation. Subjects will be randomized for assignment into three treatment conditions: eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use mental visualization of foot or hand movements, eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use an open mirror- box to visualize the reflected image of their intact foot or hand, and eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use a closed mirror- box (unable to visualize a reflected image). Subjects will use their assigned therapy for 20 minutes daily. Subjects using the closed mirror-box or mental visualization treatments will be switched to mirror therapy if they have not significantly improved following 4 weeks. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (60) subjects will be recruited and screened according to the inclusion and exclusion criteria since we expect that some may not qualify or drop-out sooner than the scheduled 4-month completion time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301444
|Contact: Jack W Tsao, MDemail@example.com|
|Contact: Richard L Witt, PA-Cfirstname.lastname@example.org|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307|
|Contact: Jack W Tsao, MD 301-295-3643 email@example.com|
|Contact: Richard L Witt, PA-C 202-782-8705 firstname.lastname@example.org|
|Principal Investigator: Jack W Tsao, MD|
|Sub-Investigator: Paul Pasquina, MD|
|Sub-Investigator: Richard L Witt, PA-C|
|Sub-Investigator: Brenda L Chan|
|Sub-Investigator: Amanda Magee, PA-C|
|Principal Investigator:||Jack W Tsao, MD||Walter Reed Army Medical Center|