Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
NCT ID: NCT00797849
Last Updated: 2012-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2008-11-30
2011-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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1
Wear prosthetics laminated with Farabloc surrounding the liner. If not wearing prosthetics, subject needs to wear Farabloc sock or glove over shrinker.
Farabloc Limb Cover
Wear prosthetics, sock or glove laminated with Farabloc
2
Wear prosthetics laminated with sham material surrounding the liner. If not wearing prosthetics, subject needs to wear sock or glove over shrinker.
Sham Limb Cover
Wear prosthetics, sock or glove laminated with sham material
Interventions
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Farabloc Limb Cover
Wear prosthetics, sock or glove laminated with Farabloc
Sham Limb Cover
Wear prosthetics, sock or glove laminated with sham material
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Experience episodes or intermittent PLP
* At least 3 episodes of PLP during the previous 6 weeks
* Have not used Farabloc within the last 6 months
Exclusion Criteria
* Stump complications (e.g., cellulites and stump pain caused by new bone spur within the past 12 months
* Previous use of Farabloc within 6 months
18 Years
ALL
No
Sponsors
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Samueli Institute for Information Biology
OTHER
Southern California Institute for Research and Education
OTHER
Responsible Party
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Southern California Institute for Research and Education
Principal Investigators
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An-Fu Hsiao, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
VA Long Beach Healthcare System
Locations
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VA Long Beach Healthcare System
Long Beach, California, United States
Countries
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References
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Adams PF, Hendershot GE, Marano MA; Centers for Disease Control and Prevention/National Center for Health Statistics. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10. 1999 Oct;(200):1-203.
Ephraim PL, Dillingham TR, Sector M, Pezzin LE, Mackenzie EJ. Epidemiology of limb loss and congenital limb deficiency: a review of the literature. Arch Phys Med Rehabil. 2003 May;84(5):747-61. doi: 10.1016/s0003-9993(02)04932-8.
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Related Links
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Southern California Institute for Research and Education Website
Other Identifiers
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Contract 1 EA-0000078
Identifier Type: -
Identifier Source: secondary_id
Subaward for W81XWH-06-1-0279
Identifier Type: -
Identifier Source: secondary_id
#871
Identifier Type: -
Identifier Source: org_study_id
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