Phantom Limb Pain Clinical Trial
Official title:
A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
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.
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, if not wearing prosthetics, subject will wear sock or
glove made of sham fabric over shrinker. All subjects will receive at least two socks.
Data for PLP pain levels and health-related quality of life will be collected during
baseline, 6-week, 12-week and 1-month post treatment follow-up. Research staff will
administer these surveys and collect data in person. The amount of health care utilization
will be measured 12-week prior ot enrollment and 12-week follow-up. Monitoring adherence to
protocol by phone call will be made during the treatment at 3-week and 9-week followup.
Study participants will receive a total of $50 for their participation in this study ($20
for baseline and $10 for each of the three follow-up visits). At the end of the study,
participants can choose to keep the active or sham Farabloc. If the true Farabloc turns out
to be an effective treatment for phantom limb pain, subjects assigned to the sham Farabloc
intervention will b offered the option to be treated with true Farabloc free of charge aftr
conclusion of the study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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