Recruiting

Mirror Therapy

Sponsor:

United States Naval Medical Center, San Diego

Code:

NCT02383979

Conditions

Phantom Limb Pain

Phantom Pain

Phantom Sensation

Pseudomelia

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Sham (Comparator) Plasma Ball

Mirror

Study Details

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

Study ID

NCT02383979

Start date

Aug, 2010

Status verified date

Aug, 2019

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

115 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Plasma Ball (Control)

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.

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.

no intervention: Non-Surgical

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

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

Mirror

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

Primary outcome measure

  • Comparing fMRI scans to see if mirror therapy helps prevent or alleviate phantom limb pain in service members undergoing amputation(s) [ Time Frame: 4 weeks prior to surgery through 1 year post operation ]

Central Contacts and Locations

Locations

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

Recruiting

San Diego, California, United States, 92134

Contacts

Principal Investigator:

Steven R Hanling, MD

More Information

Sponsor

United States Naval Medical Center, San Diego

Last update posted

Aug 28, 2019

Last verified

Aug, 2019

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Naval Medical Center, San Diego on 2019-08-28.