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

March 12, 2012 updated by: Southern California Institute for Research and Education

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822-5201
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Wear prosthetics laminated with Farabloc surrounding the liner. If not wearing prosthetics, subject needs to wear Farabloc sock or glove over shrinker.
Device: Farabloc Limb Cover
Wear prosthetics, sock or glove laminated with Farabloc
Other Names:
  • FARABLOC - LC
Sham Comparator: 2
Wear prosthetics laminated with sham material surrounding the liner. If not wearing prosthetics, subject needs to wear sock or glove over shrinker.
Device: Sham Limb Cover
Wear prosthetics, sock or glove laminated with sham material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Measurements will be obtained at baseline, and 6-week and 12-week follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
At 12-week pretreatment and 12-week follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Collaborators

Samueli Institute for Information Biology

Investigators

  • Principal Investigator: An-Fu Hsiao, M.D., Ph.D., VA Long Beach Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #871
  • Contract 1 EA-0000078
  • Subaward for W81XWH-06-1-0279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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