Phantom Limb Pain Clinical Trial
Official title:
Perioperative Visual Therapy May Help Prevent Phantom Limb Pain
Verified date | August 2019 |
Source | United States Naval Medical Center, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 115 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: Treatment (Surgical) Group: 1. Subjects age 18 years or older scheduled for elective amputation; 2. Cooperative, patient scheduled for amputation, with time and availability to do fMRI prior to their operative date; 3. Willing to perform mirror therapy for 14 days prior and post-operative procedure; 4. Subjects who opt for fMRI portion of the study are willing and/or able to tolerate fMRI. Control (Non-Surgical) Group: 1. Subjects age 18 years to 30; 2. who are non amputated and healthy; 3. Cooperative, with time and availability to do an fMRI; 4. Willing and able to tolerate fMRI. Exclusion Criteria: 1. inability to cooperate with physical therapy; and 2. possessing a contraindication to mirror therapy for example blindness or inability to position properly for the therapy 3. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
United States Naval Medical Center, San Diego |
United States,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparing fMRI scans to see if mirror therapy helps prevent or alleviate phantom limb pain in service members undergoing amputation(s) | For patients participating in the fMRI procedures, the scans will be compared among the four time-points (pre-initiation of mirror therapy (if possible), post-mirror therapy but pre-amputation, post-amputation at 4 weeks and at one year post-amputation). Primary analysis will compare the two treatment groups from baseline to 4 weeks following the initial catheter placement; but additional comparisons will be completed to help plan future investigations. | 4 weeks prior to surgery through 1 year post operation |
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