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

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.

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.