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Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain

2014-08-27 03:32:05 | BioPortfolio

Summary

Because bilateral lower extremity amputees do not have an intact limb for use with the mirror, we are now proposing to conduct a pilot trial of two treatments for PLP - direct observation of another person's foot moving versus mental visualization. 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, and the average intensity of pain in each phantom leg. 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. This study will test the hypothesis that direct observation of a limb while performing phantom limb movements will reduce phantom limb pain more than mental visualization of the phantom limb alone in subjects who have sustained a traumatic bilateral lower limb amputation.

Description

A total of forty-two (42) subjects with bilateral lower extremity amputations will be enrolled. Subjects will be randomized for assignment into two treatment conditions: twenty-one (21) subjects will use direct observation of another person's foot movements while twenty-one (21) will use mental visualization of foot movements (which will serve as the control group). Subjects in each group will be further be randomized for assignment into six treatment groups: direct observation or mental visualization of right lower extremity movements alone, direct observation or mental visualization of left lower extremity movements alone, or direct observation or mental visualization of simultaneous bilateral lower extremity movements. Subjects will use their assigned therapy for 20 minutes daily. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (50) 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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Phantom Limb Pain

Intervention

direct observation, mental visualization

Location

Walter Reed Army Medical Center
Washington
District of Columbia
United States
20307

Status

Recruiting

Source

Walter Reed Army Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:05-0400

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Medical and Biotech [MESH] Definitions

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