Status:
UNKNOWN
Study to Assess the Efficacy of Direct Observation and Mental Visualization of Foot Movements to Treat Bilateral Lower Limb Phantom Limb Pain
Lead Sponsor:
Walter Reed Army Medical Center
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Because bilateral lower extremity amputees do not have an intact limb for use with the mirror, we are now proposing to conduct a pilot trial of two treatments for phantom limb pain (PLP) - direct obse...
Detailed Description
A total of forty-two (42) subjects with bilateral lower extremity amputations will be enrolled. Subjects will be randomized for assignment into two treatment conditions: twenty-one (21) subjects will ...
Eligibility Criteria
Inclusion
- 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.
- Traumatic bilateral lower limb amputation.
- No prior history of vertebral disk disease/condition, sciatica or radiculopathy.
- Normal neurological examination.
- Minimum of 3 phantom limb pain episodes each week in one phantom leg.
- Degree of pain evaluated by VAS scoring a minimum of 3 cm at time of screening for entry into study.
- Ability to follow study instructions and likely to complete all required visits.
Exclusion
- Age less than 18 or greater than 70.
- Unilateral upper or lower limb amputation.
- Severe traumatic brain injury (TBI) - 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. Subjects with diagnosis of mild TBI following TBI testing, but with a normal score (\>42) on the Test of Memory Malingering (TOMM) (parts 1 or 2) can be included in the study.
- 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 in the 6 months prior to entry into the study, defined as a condition requiring initiation of medications or hospitalization with continuing medical treatment for the condition.
- Subjects with lack of effort as determined by the neurologist. Subjects will be screened for effort using the TOMM first in order to exclude those with blatant exaggeration or malingering.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00639431
Start Date
December 1 2007
End Date
August 1 2014
Last Update
August 12 2014
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307