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A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain
This study is currently recruiting participants.
Verified by Walter Reed Army Medical Center, April 2007
Sponsored by: Department of Defense
Information provided by: Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00301444
  Purpose

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.


Condition Intervention
Amputation
Phantom Limb
Pain
Device: mirror-box treatment
Behavioral: Mental visualization

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title: A Pilot Study to Assess the Efficacy of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Significant decrease in the level of phantom limb pain at 4 weeks.

Secondary Outcome Measures:
  • Significant decrease in the number and duration of daily phantom limb pain episodes at 4 weeks.

Estimated Enrollment: 48
Study Start Date: March 2006
Estimated Study Completion Date: June 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301444

Contacts
Contact: Jack W Tsao, MD 301-295-3643 jtsao@usuhs.mil
Contact: Richard L Witt, PA-C 202-782-8705 richard.witt@amedd.army.mil

Locations
United States, District of Columbia
Walter Reed Army Medical Center Recruiting
Washington, District of Columbia, United States, 20307
Contact: Jack W Tsao, MD     301-295-3643     jtsao@usuhs.mil    
Contact: Richard L Witt, PA-C     202-782-8705     rlwittpa1@aol.com    
Principal Investigator: Jack W Tsao, MD            
Sub-Investigator: Paul Pasquina, MD            
Sub-Investigator: Richard L Witt, PA-C            
Sub-Investigator: Brenda L Chan            
Sub-Investigator: Amanda Magee, PA-C            
Sponsors and Collaborators
Investigators
Principal Investigator: Jack W Tsao, MD Walter Reed Army Medical Center
  More Information

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.
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.
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.
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.
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.
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.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994 Mar;23(2):129-38. Review.
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7.
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.
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):217-26.
Katz J, Melzack R. Pain 'memories' in phantom limbs: review and clinical observations. Pain. 1990 Dec;43(3):319-36. Review.

Study ID Numbers: DCI P05-A008
Study First Received: March 9, 2006
Last Updated: June 13, 2007
ClinicalTrials.gov Identifier: NCT00301444  
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
phantom limb pain
limb amputation

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Pain
Phantom Limb
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009