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

NCT00797849 | Completed

• 3 other identifiers: #871Contract 1 EA-0000078Subaward for W81XWH-06-1-0279
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Phantom Limb Pain

Keywords

phantom limb pain; amputees; Farabloc; Phantom limb pain in the missing limb of Veteran amputees

Outcome Measures

Primary Outcomes (1)

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

  Measurements will be obtained at baseline, and 6-week and 12-week follow-ups

Secondary Outcomes (2)

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

  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.

  At 12-week pretreatment and 12-week follow-up.

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

SHAM COMPARATOR

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

Interventions

Farabloc Limb Cover DEVICE

Wear prosthetics, sock or glove laminated with Farabloc

Also known as: FARABLOC - LC

1

Sham Limb Cover DEVICE

Wear prosthetics, sock or glove laminated with sham material

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern California Institute for Research and Education: lead
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822-5201, United States

Location

Related Publications (25)

• 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.

  PMID: 15782448 BACKGROUND

• 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.

  PMID: 12736892 BACKGROUND

• 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.

  PMID: 17003197 BACKGROUND

• 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.

  PMID: 15105752 BACKGROUND

• 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.

  PMID: 10870364 BACKGROUND

• 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.

  PMID: 8288381 BACKGROUND

• Sherman RA. Phantom limb pain. Mechanism-based management. Clin Podiatr Med Surg. 1994 Jan;11(1):85-106.

  PMID: 8124659 BACKGROUND

• 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.

  PMID: 16213230 BACKGROUND

• 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.

  PMID: 10863043 BACKGROUND

• 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.

  PMID: 12551807 BACKGROUND

• 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.

  PMID: 16691088 BACKGROUND

• 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.

  PMID: 15497918 BACKGROUND

• 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.

  PMID: 6709380 BACKGROUND

• 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.

  PMID: 9215014 BACKGROUND

• 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.

  PMID: 8118694 BACKGROUND

• 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.

  PMID: 11390778 BACKGROUND

• 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.

  PMID: 9535570 BACKGROUND

• 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.

  PMID: 2710561 BACKGROUND

• 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.

  PMID: 4741689 BACKGROUND

• 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.

  PMID: 7116073 BACKGROUND

• 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.

  PMID: 7838588 BACKGROUND

• 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.

  PMID: 10534586 BACKGROUND

• 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.

  PMID: 8277801 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 10446661 BACKGROUND

Related Links

• Southern California Institute for Research and Education Website

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• An-Fu Hsiao, M.D., Ph.D.

  VA Long Beach Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

US (1)