Ignite Creation Date:
2025-12-18 @ 9:11 AM
Ignite Modification Date:
2025-12-18 @ 9:11 AM
Study NCT ID:
NCT00797849
Status:
None
Last Update Posted:
2012-03-14 00:00:00
First Post:
2008-11-24 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Sponsor:
None
Organization:
Study Overview
Official Title:
A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Status:
None
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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, 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: