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
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
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
NCT ID
NCT00797849
First Posted
November 24, 2008
Last Updated
March 12, 2012
Sponsor
Southern California Institute for Research and Education
Collaborators
Samueli Institute for Information Biology
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
Citations:
PubMed Identifier
15782448
Citation
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.
Results Reference
background
PubMed Identifier
12736892
Citation
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.
Results Reference
background
PubMed Identifier
17003197
Citation
Potter BK, Scoville CR. Amputation is not isolated: an overview of the US Army Amputee Patient Care Program and associated amputee injuries. J Am Acad Orthop Surg. 2006;14(10 Spec No.):S188-90. doi: 10.5435/00124635-200600001-00041.
Results Reference
background
PubMed Identifier
15105752
Citation
Lin DL, Kirk KL, Murphy KP, McHale KA, Doukas WC. Evaluation of orthopaedic injuries in Operation Enduring Freedom. J Orthop Trauma. 2004 May-Jun;18(5):300-5. doi: 10.1097/00005131-200405000-00006.
Results Reference
background
PubMed Identifier
10870364
Citation
Islinger RB, Kuklo TR, McHale KA. A review of orthopedic injuries in three recent U.S. military conflicts. Mil Med. 2000 Jun;165(6):463-5.
Results Reference
background
PubMed Identifier
8288381
Citation
Korver AJ. Amputees in a hospital of the International Committee of the Red Cross. Injury. 1993 Oct;24(9):607-9. doi: 10.1016/0020-1383(93)90124-o.
Results Reference
background
PubMed Identifier
8124659
Citation
Sherman RA. Phantom limb pain. Mechanism-based management. Clin Podiatr Med Surg. 1994 Jan;11(1):85-106.
Results Reference
background
PubMed Identifier
16213230
Citation
Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031.
Results Reference
background
PubMed Identifier
10863043
Citation
Kooijman CM, Dijkstra PU, Geertzen JHB, Elzinga A, van der Schans CP. Phantom pain and phantom sensations in upper limb amputees: an epidemiological study. Pain. 2000 Jul;87(1):33-41. doi: 10.1016/S0304-3959(00)00264-5.
Results Reference
background
PubMed Identifier
12551807
Citation
Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9.
Results Reference
background
PubMed Identifier
16691088
Citation
Richardson C, Glenn S, Nurmikko T, Horgan M. Incidence of phantom phenomena including phantom limb pain 6 months after major lower limb amputation in patients with peripheral vascular disease. Clin J Pain. 2006 May;22(4):353-8. doi: 10.1097/01.ajp.0000177793.01415.bd.
Results Reference
background
PubMed Identifier
15497918
Citation
Whyte A, Niven CA. The illusive phantom: does primary care meet patient need following limb loss? Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):894-900. doi: 10.1080/09638280410001708904.
Results Reference
background
PubMed Identifier
6709380
Citation
Sherman RA, Sherman CJ, Parker L. Chronic phantom and stump pain among American veterans: results of a survey. Pain. 1984 Jan;18(1):83-95. doi: 10.1016/0304-3959(84)90128-3.
Results Reference
background
PubMed Identifier
9215014
Citation
Wartan SW, Hamann W, Wedley JR, McColl I. Phantom pain and sensation among British veteran amputees. Br J Anaesth. 1997 Jun;78(6):652-9. doi: 10.1093/bja/78.6.652.
Results Reference
background
PubMed Identifier
8118694
Citation
Amir R, Devor M. Ongoing activity in neuroma afferents bearing retrograde sprouts. Brain Res. 1993 Dec 10;630(1-2):283-8. doi: 10.1016/0006-8993(93)90667-c.
Results Reference
background
PubMed Identifier
11390778
Citation
Jain N, Florence SL, Kaas JH. Reorganization of Somatosensory Cortex After Nerve and Spinal Cord Injury. News Physiol Sci. 1998 Jun;13:143-149. doi: 10.1152/physiologyonline.1998.13.3.143.
Results Reference
background
PubMed Identifier
9535570
Citation
Flor H, Elbert T, Muhlnickel W, Pantev C, Wienbruch C, Taub E. Cortical reorganization and phantom phenomena in congenital and traumatic upper-extremity amputees. Exp Brain Res. 1998 Mar;119(2):205-12. doi: 10.1007/s002210050334.
Results Reference
background
PubMed Identifier
2710561
Citation
Chabal C, Jacobson L, Russell LC, Burchiel KJ. Pain responses to perineuromal injection of normal saline, gallamine, and lidocaine in humans. Pain. 1989 Mar;36(3):321-325. doi: 10.1016/0304-3959(89)90091-2.
Results Reference
background
PubMed Identifier
4741689
Citation
Parkes CM. Factors determining the persistence of phantom pain in the amputee. J Psychosom Res. 1973 Mar;17(2):97-108. doi: 10.1016/0022-3999(73)90010-x. No abstract available.
Results Reference
background
PubMed Identifier
7116073
Citation
Shukla GD, Sahu SC, Tripathi RP, Gupta DK. Phantom limb: a phenomenological study. Br J Psychiatry. 1982 Jul;141:54-8. doi: 10.1192/bjp.141.1.54.
Results Reference
background
PubMed Identifier
7838588
Citation
Jensen MP, Turner JA, Romano JM. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994 Sep;58(3):387-392. doi: 10.1016/0304-3959(94)90133-3.
Results Reference
background
PubMed Identifier
10534586
Citation
Jensen MP, Turner JA, Romano JM, Fisher LD. Comparative reliability and validity of chronic pain intensity measures. Pain. 1999 Nov;83(2):157-62. doi: 10.1016/s0304-3959(99)00101-3.
Results Reference
background
PubMed Identifier
8277801
Citation
McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
10446661
Citation
Kazis LE, Ren XS, Lee A, Skinner K, Rogers W, Clark J, Miller DR. Health status in VA patients: results from the Veterans Health Study. Am J Med Qual. 1999 Jan-Feb;14(1):28-38. doi: 10.1177/106286069901400105.
Results Reference
background
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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