Perioperative Mirror Therapy and Phantom Limb Pain

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Phantom Limb Pain, Phantom Pain, Phantom Sensation, Pseudomelia

In brief

Mirror therapy will consist of observing the unaffected limb reflected in a mirror positioned in the midline to block the view of the affected limb. All therapy sessions will be supervised by a physical therapist with the exception of weekends when the patients will continue therapy on an independent basis. In an effort to objectively demonstrate cortical reorganization associated with mirror therapy, patients can elect to participate in a functional MRI (fMRI) portion of the study. The fMRI would be evaluated prior to initiating the experimental or control therapy (Due to the sensitive timeline in this population and its effect on recruitment, we have amended the protocol to allow recruitment and enrollment to take place even if the timeline does not allow for the fMRI to be executed 2 weeks prior to amputation. Though this would be ideal, we will accept subjects that are only available for day before amputation scans), just before the operative procedure, at four weeks post-operation and then again at one year. All subjects will be evaluated at 4 weeks, 8 weeks (functional physical therapy (PT) tests only) 12 weeks, and 12 months postoperatively to determine 1) the incidence, severity and functional impact of phantom limb pain 2)the ability to meet various specialists' endpoints, to include participation in physical therapy, and 3) overall quality of life which the patients can describe subjectively. This therapy could have a dramatic impact on the long term prognosis of amputees whether due to trauma, metabolic conditions, tumor, or peripheral vascular disease. This protocol will include performing fMRIs on a cohort of healthy, active duty, age matched, male personnel to create reference data to compare the fMRI data of study participants.

Key facts

Study ID

NCT02383979

Run by

United States Naval Medical Center, San Diego

People needed

115

Starts

2010-08-01

Expected to finish

2019-08-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 30. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Treatment (Surgical) Group:
• Subjects age 18 years or older scheduled for elective amputation;
• Cooperative, patient scheduled for amputation, with time and availability to do fMRI prior to their operative date;
• Willing to perform mirror therapy for 14 days prior and post-operative procedure;
• Subjects who opt for fMRI portion of the study are willing and/or able to tolerate fMRI.
• Control (Non-Surgical) Group:
• Subjects age 18 years to 30;
• who are non amputated and healthy;
• Cooperative, with time and availability to do an fMRI;
• Willing and able to tolerate fMRI.

You may not qualify if…

• inability to cooperate with physical therapy; and
• possessing a contraindication to mirror therapy for example blindness or inability to position properly for the therapy
• primary central nervous disease such as status post cerebral vascular accident with persistent deficit, Alzheimer's disease or Multiple Sclerosis. In addition, patients with claustrophobia will be excluded from participating in the fMRI portion of this study.

Where it is running

• Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San Diego — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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