Phantom Limb PainNCT00797849
Controlled Study of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
A study testing Farabloc Limb Cover in people with Phantom Limb Pain, run by Southern California Institute for Research and Education at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phantom Limb Pain
- What is being tested?
- Farabloc Limb Cover
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System
Long Beach, California, 90822-5201
About this study
Official title: 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.
Read the 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.
- Conditions
- Phantom Limb Pain
- Being tested
- Farabloc Limb Cover, Sham Limb Cover
- Keywords
- phantom limb pain, amputees, Farabloc, Phantom limb pain in the missing limb of Veteran amputees
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farabloc Limb CoverDevice
Also called FARABLOC - LC
Wear prosthetics, sock or glove laminated with Farabloc
Sham Limb CoverDevice
Wear prosthetics, sock or glove laminated with sham material
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Limb Cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be pain as measured by the Numerical Pain Rating Scale (NPRS).
Measured: 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).
Measured: 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.
Measured: At 12-week pretreatment and 12-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Phantom Limb PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Samueli Institute for Information Biology
- Investigators
- An-Fu Hsiao, M.D., Ph.D., Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797849
- Sponsor's protocol ID
- #871
- Other IDs
- Contract 1 EA-0000078, Subaward for W81XWH-06-1-0279
- Status last verified
- Mar 2012
- First submitted
- 24 Nov 2008
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15782448Ephraim 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.
PubMed 12736892Potter 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.
PubMed 17003197Lin 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.
PubMed 15105752Islinger 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.
PubMed 10870364Korver 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.
PubMed 8288381Sherman RA. Phantom limb pain. Mechanism-based management. Clin Podiatr Med Surg. 1994 Jan;11(1):85-106.
PubMed 8124659Ephraim 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.
PubMed 16213230Kooijman 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.
PubMed 10863043Dijkstra 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.
PubMed 12551807Richardson 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.
PubMed 16691088Whyte 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.
PubMed 15497918Sherman 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.
PubMed 6709380Wartan 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.
PubMed 9215014Amir 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.
PubMed 8118694
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Effectiveness of Farabloc for Chronic Phantom Limb Pain Among Veteran Amputees
- ClinicalTrials.gov ID
- NCT00797849
- Acronym / sponsor ID
- #871
- Conditions
- Phantom Limb Pain
- Keywords
- phantom limb pain, amputees, Farabloc, Phantom limb pain in the missing limb of Veteran amputees
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Samueli Institute for Information Biology
- Study start
- Nov 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Farabloc Limb CoverWear prosthetics laminated with Farabloc surrounding the liner. If not wearing prosthetics, subject needs to wear Farabloc sock or glove over shrinker. |
| 2 | Sham comparator | Device: Sham Limb CoverWear prosthetics laminated with sham material surrounding the liner. If not wearing prosthetics, subject needs to wear sock or glove over shrinker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Farabloc Limb CoverAlso: FARABLOC - LCWear prosthetics, sock or glove laminated with Farabloc | Device | 1 |
| Sham Limb CoverWear prosthetics, sock or glove laminated with sham material | Device | 2 |
Primary outcome
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
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Background: PubMed 15782448Adams 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.
- Background: PubMed 12736892Ephraim 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.
- Background: PubMed 17003197Potter 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.
- Background: PubMed 15105752Lin 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.
- Background: PubMed 10870364Islinger 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.
- Background: PubMed 8288381Korver 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.
- Background: PubMed 8124659Sherman RA. Phantom limb pain. Mechanism-based management. Clin Podiatr Med Surg. 1994 Jan;11(1):85-106.
- Background: PubMed 16213230Ephraim 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.
- Background: PubMed 10863043Kooijman 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.
- Background: PubMed 12551807Dijkstra 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.
- Background: PubMed 16691088Richardson 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.
- Background: PubMed 15497918Whyte 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.
- Southern California Institute for Research and Education WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An-Fu Hsiao, M.D., Ph.D. principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Farabloc Limb Cover in people with Phantom Limb Pain, run by Southern California Institute for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00797849, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.