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

This study has been completed.
Sponsor:
Collaborator:
Samueli Institute for Information Biology
Information provided by:
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT00797849
First received: November 24, 2008
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Phantom Limb Pain
Device: Farabloc Limb Cover
Device: Sham Limb Cover

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: November 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • FARABLOC LIMB COVER
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797849

Locations
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822-5201
Sponsors and Collaborators
Southern California Institute for Research and Education
Samueli Institute for Information Biology
Investigators
Principal Investigator: An-Fu Hsiao, M.D., Ph.D. VA Long Beach Healthcare System
  More Information

Additional Information:
Publications:

Responsible Party: An-Fu Hsiao, M.D., Ph.D., Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT00797849     History of Changes
Other Study ID Numbers: #871, Contract 1 EA-0000078, Subaward for W81XWH-06-1-0279
Study First Received: November 24, 2008
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Southern California Institute for Research and Education:
phantom limb pain
amputees
Farabloc
Phantom limb pain in the missing limb of Veteran amputees

Additional relevant MeSH terms:
Phantom Limb
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Pain
Pain, Postoperative
Pathologic Processes
Perceptual Disorders
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014