A Study to Test the Effectiveness of Mirror-Box and Mental Visualization Treatments on Phantom Limb Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Walter Reed Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00301444
First received: March 9, 2006
Last updated: June 13, 2007
Last verified: April 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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

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

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on September 18, 2014