Recruiting

Mirror-Box & Mental Visualization

Sponsor:

United States Department of Defense

Code:

NCT00301444

Conditions

Amputation

Phantom Limb

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

mirror-box treatment

Mental visualization

Study Details

Brief 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 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.

Conditions

Amputation

Phantom Limb

Pain

Study ID

NCT00301444

Start date

Mar, 2006

Status verified date

Apr, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

mirror-box treatment

Mental visualization

Primary outcome measure

  • Significant decrease in the level of phantom limb pain at 4 weeks. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Jack W Tsao, MD

301-295-3643jtsao@usuhs.mil

Richard L Witt, PA-C

202-782-8705richard.witt@amedd.army.mil

Locations

Walter Reed Army Medical Center

Recruiting

Washington, District of Columbia, United States, 20307

Contacts

Jack W Tsao, MD

301-295-3643jtsao@usuhs.mil

Richard L Witt, PA-C

202-782-8705rlwittpa1@aol.com

Principal Investigator:

Jack W Tsao, MD

More Information

Sponsor

United States Department of Defense

Last update posted

Jun 14, 2007

Last verified

Apr, 2007

Keywords

  • phantom limb pain
  • limb amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Department of Defense on 2007-06-14.