Perioperative Mirror Therapy and Phantom Limb Pain

NCT02383979 | Unknown Phase 4 DMC

• 1 other identifier: NMCSD.2010.0007
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phantom Limb Pain; Phantom Pain; Phantom Sensation; Pseudomelia

Keywords

Phantom limb pain; Mirror therapy; Elective amputation; Residual limb pain; Functional MRI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Plasma Ball (Control)

SHAM COMPARATOR

Subjects randomized to standard therapy will participate 14 days of daily mirror therapy sessions preoperatively which will consist of undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere.

Device: Sham (Comparator) Plasma Ball

Experimental

EXPERIMENTAL

Subjects randomized to the mirror therapy limb will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb.

Device: Mirror

Non-Surgical

NO INTERVENTION

Subjects will undergo 3 questionnaires and one functional fMRI exam. Imaging protocol will be identical to preoperative imaging protocol for amputation subjects. This data will aid in establishing baseline fMR activation values for all fMR paradigms tested. The control group will not be randomized to receive either perioperative plasma ball (sham) or mirror therapy.

Interventions

Sham (Comparator) Plasma Ball DEVICE

will consist of undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere.

Plasma Ball (Control)

Mirror DEVICE

will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb

Experimental

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San Diego

San Diego, California, 92134, United States

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Phantom Limb

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Steven R Hanling, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: August 1, 2010
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)