AmputationNCT00301444
A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
A study testing mirror-box treatment and Mental visualization in people with Amputation and Phantom Limb, run by United States Department of Defense at 1 site in United States.
Trial summary
The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Phantom Limb, Pain
- What is being tested?
- mirror-box treatment and Mental visualization
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2008
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 to 70 years of age, active duty military, beneficiary, or retiree.
- Written informed consent and written authorization for use or release of health and research study information.
- Any single unilateral upper or lower limb amputation with the presence of phantom limb pain.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Normal neurological examination.
- Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into the study, with a minimum of three episodes per week.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- Age less than 18 or greater than 70.
- Bilateral upper or lower limb amputation.
- Presence of traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record.
- Known uncontrolled systemic disease- known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
- Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- Significant Axis I or II diagnosis determined by a neurologist or psychiatrist in the 6 months prior to entry into the study.
- Subjects with lack of effort as determined by the neurologist or physiatrist. Subjects will be screened for effort using the Test of Memory Malingering (TOMM) first in order to exclude those with blatant exaggeration or malingering.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Jack W Tsao, MD, 301-295-3643, jtsao@usuhs.mil
Richard L Witt, PA-C, 202-782-8705, rlwittpa1@aol.com
About this study
Official title: A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
The researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average intensity of pain, and worst intensity of pain. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (> 3 months) limb amputation.
The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.
Read the detailed description
A total of forty-eight (48) subjects with be enrolled - twenty-four (24) with any unilateral lower limb amputation and twenty-four (24) with any unilateral upper limb amputation. Subjects will be randomized for assignment into three treatment conditions: eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use mental visualization of foot or hand movements, eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use an open mirror- box to visualize the reflected image of their intact foot or hand, and eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use a closed mirror- box (unable to visualize a reflected image). Subjects will use their assigned therapy for 20 minutes daily. Subjects using the closed mirror-box or mental visualization treatments will be switched to mirror therapy if they have not significantly improved following 4 weeks. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (60) subjects will be recruited and screened according to the inclusion and exclusion criteria since we expect that some may not qualify or drop-out sooner than the scheduled 4-month completion time.
- Conditions
- Amputation, Phantom Limb, Pain
- Being tested
- mirror-box treatment, Mental visualization
- Keywords
- phantom limb pain, limb amputation
- Medical subject headings
- Phantom Limb, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror-box treatmentDevice
Mental visualizationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant decrease in the level of phantom limb pain at 4 weeks.
Secondary outcomes (1)
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMar 2006
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Department of Defense
- Sponsor type
- US federal agency
- Investigators
- Jack W Tsao, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301444
- Sponsor's protocol ID
- DCI P05-A008
- Status last verified
- Apr 2007
- First submitted
- 9 Mar 2006
- Last updated
- 14 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. doi: 10.1212/wnl.28.3.211.
PubMed 564474Sherman 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 6709380Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.
PubMed 7777055MacLachlan M, McDonald D, Waloch J. Mirror treatment of lower limb phantom pain: a case study. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):901-4. doi: 10.1080/09638280410001708913.
PubMed 15497919Jackson PL, Lafleur MF, Malouin F, Richards CL, Doyon J. Functional cerebral reorganization following motor sequence learning through mental practice with motor imagery. Neuroimage. 2003 Oct;20(2):1171-80. doi: 10.1016/S1053-8119(03)00369-0.
PubMed 14568486Ramachandran VS, Altschuler EL, Stone L, Al-Aboudi M, Schwartz E, Siva N. Can mirrors alleviate visual hemineglect? Med Hypotheses. 1999 Apr;52(4):303-5. doi: 10.1054/mehy.1997.0651.
PubMed 10465667Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Ochipa C, Rapcsak SZ, Maher LM, Rothi LJ, Bowers D, Heilman KM. Selective deficit of praxis imagery in ideomotor apraxia. Neurology. 1997 Aug;49(2):474-80. doi: 10.1212/wnl.49.2.474.
PubMed 9270580Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.
PubMed 8008411Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-336. doi: 10.1016/0304-3959(90)90029-D.
PubMed 2293143Finn SB, Perry BN, Clasing JE, Walters LS, Jarzombek SL, Curran S, Rouhanian M, Keszler MS, Hussey-Andersen LK, Weeks SR, Pasquina PF, Tsao JW. A Randomized, Controlled Trial of Mirror Therapy for Upper Extremity Phantom Limb Pain in Male Amputees. Front Neurol. 2017 Jul 7;8:267. doi: 10.3389/fneur.2017.00267. eCollection 2017.
PubMed 28736545
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00301444
- Acronym / sponsor ID
- DCI P05-A008
- Conditions
- Amputation, Phantom Limb, Pain
- Keywords
- phantom limb pain, limb amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- United States Department of DefenseUS federal agency
- Study start
- Mar 2006
- Study completion
- Jun 2008 (estimated)
- First posted
- 10 Mar 2006 (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 researchers propose to conduct a pilot study on the efficacy of mirror-box and mental visualization treatments on phantom limb pain. The trial will last for 4 months and during the first month, data will be gathered daily on the number of episodes of phantom limb pain, the average length of episodes, average intensity of pain, and worst intensity of pain. In addition, the rapidity of pain relief, the length of therapy needed to sustain long-lasting pain relief, and whether use of these two treatment methods during rehabilitation can provide sustained and/or permanent pain relief will be determined. Cognitive testing will also be performed to determine the effect of limb amputation on cognition and mood with results being compared to an on-going study of similar effects in patients with chronic (> 3 months) limb amputation.
The inclusion of subjects with phantom limb pain in upper extremity amputations has recently been approved.
Detailed description
A total of forty-eight (48) subjects with be enrolled - twenty-four (24) with any unilateral lower limb amputation and twenty-four (24) with any unilateral upper limb amputation. Subjects will be randomized for assignment into three treatment conditions: eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use mental visualization of foot or hand movements, eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use an open mirror- box to visualize the reflected image of their intact foot or hand, and eight (8) lower and eight (8) upper limb subjects (50% with left-sided amputations) will use a closed mirror- box (unable to visualize a reflected image). Subjects will use their assigned therapy for 20 minutes daily. Subjects using the closed mirror-box or mental visualization treatments will be switched to mirror therapy if they have not significantly improved following 4 weeks. The subjects for this study will be recruited from the Walter Reed Army Medical Center Amputee clinic. Up to sixty (60) subjects will be recruited and screened according to the inclusion and exclusion criteria since we expect that some may not qualify or drop-out sooner than the scheduled 4-month completion time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 to 70 years of age, active duty military, beneficiary, or retiree.
- Written informed consent and written authorization for use or release of health and research study information.
- Any single unilateral upper or lower limb amputation with the presence of phantom limb pain.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Normal neurological examination.
Key exclusion criteria (8 listed)
- Age less than 18 or greater than 70.
- Bilateral upper or lower limb amputation.
- Presence of traumatic brain injury - permanent or temporary impairments of cognitive, physical, and psychosocial functions with an associated diminished or altered state of consciousness - as indicated by neuropsychological screening which is currently performed routinely on patients by the TBI program at WRAMC and noted in the patient's medical record.
- Known uncontrolled systemic disease- known cancer not in remission, known on-going infection, lupus, kidney disease requiring dialysis, any other systemic disease which might affect ability to participate in this study to its conclusion
- Concurrent participation in another investigational drug or device study for phantom limb pain or participation in the 30 days immediately prior to study enrollment.
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 |
|---|---|---|
| mirror-box treatment | Device | – |
| Mental visualization | Behavioural | – |
Primary outcome
Significant decrease in the level of phantom limb pain at 4 weeks.
1 secondary outcome
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2007.
- Background: PubMed 564474Carlen PL, Wall PD, Nadvorna H, Steinbach T. Phantom limbs and related phenomena in recent traumatic amputations. Neurology. 1978 Mar;28(3):211-7. doi: 10.1212/wnl.28.3.211.
- Background: PubMed 6709380Sherman 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.
- Background: PubMed 7777055Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.
- Background: PubMed 15497919MacLachlan M, McDonald D, Waloch J. Mirror treatment of lower limb phantom pain: a case study. Disabil Rehabil. 2004 Jul 22-Aug 5;26(14-15):901-4. doi: 10.1080/09638280410001708913.
- Background: PubMed 14568486Jackson PL, Lafleur MF, Malouin F, Richards CL, Doyon J. Functional cerebral reorganization following motor sequence learning through mental practice with motor imagery. Neuroimage. 2003 Oct;20(2):1171-80. doi: 10.1016/S1053-8119(03)00369-0.
- Background: PubMed 10465667Ramachandran VS, Altschuler EL, Stone L, Al-Aboudi M, Schwartz E, Siva N. Can mirrors alleviate visual hemineglect? Med Hypotheses. 1999 Apr;52(4):303-5. doi: 10.1054/mehy.1997.0651.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Background: PubMed 9270580Ochipa C, Rapcsak SZ, Maher LM, Rothi LJ, Bowers D, Heilman KM. Selective deficit of praxis imagery in ideomotor apraxia. Neurology. 1997 Aug;49(2):474-80. doi: 10.1212/wnl.49.2.474.
- Background: PubMed 8008411Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.
- Background: PubMed 2293143Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-336. doi: 10.1016/0304-3959(90)90029-D.
- Derived from this study: PubMed 28736545Finn SB, Perry BN, Clasing JE, Walters LS, Jarzombek SL, Curran S, Rouhanian M, Keszler MS, Hussey-Andersen LK, Weeks SR, Pasquina PF, Tsao JW. A Randomized, Controlled Trial of Mirror Therapy for Upper Extremity Phantom Limb Pain in Male Amputees. Front Neurol. 2017 Jul 7;8:267. doi: 10.3389/fneur.2017.00267. eCollection 2017.
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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.
Jack W Tsao, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror-box treatment and Mental visualization in people with Amputation and Phantom Limb, run by United States Department of Defense 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Jun 2007. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack W Tsao, MD (301-295-3643, jtsao@usuhs.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant decrease in the level of phantom limb pain at 4 weeks.. 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 NCT00301444, which also lists 12 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 Jun 2007.