Clinical Trial: Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Brief Summary: The primary purpose of this study is to determine if the group using Farabloc shows a greater reduction in pain levels than the group not using Farabloc at 6-week, 12-week and 1-month post treatment follow-ups.
Detailed Summary:
Phantom limb pain (PLP)is a painful sensation perceived in the missing limb after amputation and may be triggered by episodes of stump pain. A growing body of literature indicates that 50-80% of amputees may have PLP. Farabloc cloth is a noninvasive, alternative therapy developed by Farabloc Development Corporation for use by amputees with PLP. The Farabloc Corporation will be donating them to the VA Long Beach for use in this study without charge. Farabloc is a non-toxic and non-invasive treatment with promising preliminary pilot data. Metallic fibers consisting mainly of iron (85.3%) and nickel (10.0%) are woven into a nylon fabric that can be custom made into socks, gloves, limb covers, etc. Farabloc can be laminated into the socket and in the design of the prosthetic without weakening or adding significant weight to it. The exact mechanism of action is unknown for Farabloc, however, it is theorized that the fabric shields high frequency electromagnetic fields that may cause cellular damage and subsequent pain.
Subjects over 18 will be recruited from the VA Long Beach Prosthetic Clinic. Eligible subjects who are interested to participate, will be scheduled for a screening visit. Written informed consent will be obtained before enrollment. Enrolled subjects will be randomly assigned to either the Farabloc or sham Farabloc group. Assignment is double-blind to study participants, prosthetist, Farabloc Corporation and the research assistant throughout the study. Only the project coordinator and PI will know the random assignment.
Farabloc intervention will consist of wearing prosthetics laminated with Farabloc surrounding the liner or, if not wearing prosthetics, subject will wear Farabloc sock or glove over shrinker. Sham intervention will consist of wearing prosthetics laminated with sham fabric surrounding the liner or,
Sponsor: Southern California Institute for Research and Education
Current Primary Outcome: The primary outcome will be pain as measured by the Numerical Pain Rating Scale (NPRS). [ Time Frame: Measurements will be obtained at baseline, and 6-week and 12-week follow-ups ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- A secondary outcome will measure health-related quality of life using the 36-item Sort Form Health Survey (SF-36). [ Time Frame: The assessment will be conducted at pretest, 6-week, 12-week and 1-month post treatment. ]
- Measurement of health care utilization will be conducted by comparing the numbers of outpatient visits emergency room visits and inpatient hospitalizations using the VA electronic medical system CPRS. [ Time Frame: At 12-week pretreatment and 12-week follow-up. ]
Original Secondary Outcome: Same as current
Information By: Southern California Institute for Research and Education
Dates:
Date Received: November 24, 2008
Date Started: November 2008
Date Completion:
Last Updated: March 12, 2012
Last Verified: March 2012
