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Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees

Primary Purpose

Phantom Limb Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Farabloc Limb Cover
Sham Limb Cover
Sponsored by
Southern California Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Phantom Limb Pain focused on measuring phantom limb pain, amputees, Farabloc, Phantom limb pain in the missing limb of Veteran amputees

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Upper or lower extremity amputees with healed stumps
  • 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:

  • Pregnant women are excluded from the study
  • 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

Sites / Locations

  • VA Long Beach Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

1

2

Arm Description

Wear prosthetics laminated with Farabloc surrounding the liner. If not wearing prosthetics, subject needs to wear Farabloc sock or glove over shrinker.

Wear prosthetics laminated with sham material surrounding the liner. If not wearing prosthetics, subject needs to wear sock or glove over shrinker.

Outcomes

Primary Outcome Measures

The primary outcome will be pain as measured by the Numerical Pain Rating Scale (NPRS).

Secondary Outcome Measures

A secondary outcome will measure health-related quality of life using the 36-item Sort Form Health Survey (SF-36).
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.

Full Information

First Posted
November 24, 2008
Last Updated
March 12, 2012
Sponsor
Southern California Institute for Research and Education
Collaborators
Samueli Institute for Information Biology
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1. Study Identification

Unique Protocol Identification Number
NCT00797849
Brief Title
Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Official Title
A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southern California Institute for Research and Education
Collaborators
Samueli Institute for Information Biology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
phantom limb pain, amputees, Farabloc, Phantom limb pain in the missing limb of Veteran amputees

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Wear prosthetics laminated with Farabloc surrounding the liner. If not wearing prosthetics, subject needs to wear Farabloc sock or glove over shrinker.
Arm Title
2
Arm Type
Sham Comparator
Arm Description
Wear prosthetics laminated with sham material surrounding the liner. If not wearing prosthetics, subject needs to wear sock or glove over shrinker.
Intervention Type
Device
Intervention Name(s)
Farabloc Limb Cover
Other Intervention Name(s)
FARABLOC - LC
Intervention Description
Wear prosthetics, sock or glove laminated with Farabloc
Intervention Type
Device
Intervention Name(s)
Sham Limb Cover
Intervention Description
Wear prosthetics, sock or glove laminated with sham material
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Upper or lower extremity amputees with healed stumps 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: Pregnant women are excluded from the study 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An-Fu Hsiao, M.D., Ph.D.
Organizational Affiliation
VA Long Beach Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822-5201
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.scire-lb.org/
Description
Southern California Institute for Research and Education Website

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Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees

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