- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301444
A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20307
- Recruiting
- Walter Reed Army Medical Center
-
Contact:
- Richard L Witt, PA-C
- Phone Number: 202-782-8705
- Email: rlwittpa1@aol.com
-
Principal Investigator:
- Jack W Tsao, MD
-
Sub-Investigator:
- Paul Pasquina, MD
-
Sub-Investigator:
- Richard L Witt, PA-C
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Sub-Investigator:
- Brenda L Chan
-
Sub-Investigator:
- Amanda Magee, PA-C
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Significant decrease in the level of phantom limb pain at 4 weeks.
|
Secondary Outcome Measures
Outcome Measure |
---|
Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Price 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.
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- 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.
- 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.
- Flor 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.
- MacLachlan 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.
- Jackson 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.
- Ramachandran 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.
- Ochipa 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.
- Katz 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.
- Finn 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.
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCI P05-A008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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