- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383979
Perioperative Mirror Therapy and Phantom Limb Pain
Perioperative Visual Therapy May Help Prevent Phantom Limb Pain
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Subjects scheduled for amputation will be randomized to either receive perioperative plasma ball (sham) or mirror therapy, which involves a daily session of 30 minutes of performing physical therapy exercises using either a mirror or plasma ball under the supervision of a certified physical therapist. Subjects scheduled to undergo limb amputation who opt in for the fMRI portion of the study will undergo a pre-treatment baseline fMRI (2 weeks prior to scheduled amputation, if possible, but as late as 1 day pre-operative), a post-mirror or sham therapy (preoperative-day before) fMRI, post-operative fMRI at 4 weeks and one year. Performing a baseline fMRI prior to any treatment, will provide objective data regarding the location and extent of cortical involvement prior to initiating mirror therapy. Those 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. Those randomized to standard therapy will participate in an equivalent period of time undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere. 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. The subjects will then undergo a repeat fMRI (or first baseline, depending if pre-operative fMRI was possible) after completion of preoperative mirror or sham therapies and prior to surgical amputation to evaluate for changes suggestive of mirror therapy induced normalization in cortical patterns.
Control subject group 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.
All Subjects scheduled for surgery will then undergo amputation under the anesthetic technique of provider choice. If regional/neuraxial anesthetic techniques are used they will be standardized up to 1 day preoperative and 3 days postoperative. If using dexmedetomidine and/or ketamine infusions, their use will be limit to intraoperative periods at doses of 0.2 mcg/kg/hr and 0.15mg/kg/hr limit respectively. Anesthesiologist/Anesthetist choice will be permitted for all other intraoperative and postoperative meds. Within 1 week of amputation subjects will again repeat 14 days of their respectively assigned therapy limbs as described above in addition to routine post amputation care. All subjects will then be evaluated at four weeks postoperatively with measures delineated in section 5.(Statistics) to determine 1) incidence and severity of phantom limb pain 2) participation in therapy and ability to meet functional endpoints 3) quality of life. These same measures will be assessed at 12 weeks (3 months) and again at one year post procedure. A repeat fMRI will be obtained in those Subjects participating in the fMRI limb in order to evaluate how the postoperative cortical mapping compares to prior preoperative and postoperative studies.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
San Diego, California, United States, 92134
- Recruiting
- Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San Diego
-
Contact:
- Lillian G Murray, MPH
- Phone Number: 619-804-7765
- Email: lillian.g.murray2.ctr@mail.mil
-
Principal Investigator:
- Steven R Hanling, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Publications and helpful links
General Publications
- BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Mishra S, Bhatnagar S, Gupta D, Diwedi A. Incidence and management of phantom limb pain according to World Health Organization analgesic ladder in amputees of malignant origin. Am J Hosp Palliat Care. 2007 Dec-2008 Jan;24(6):455-62. doi: 10.1177/1049909107304558. Epub 2007 Sep 21.
- Ramachandran VS, Hirstein W. The perception of phantom limbs. The D. O. Hebb lecture. Brain. 1998 Sep;121 ( Pt 9):1603-30. doi: 10.1093/brain/121.9.1603.
- Flor H, Birbaumer N. Phantom limb pain: cortical plasticity and novel therapeutic approaches. Curr Opin Anaesthesiol. 2000 Oct;13(5):561-4. doi: 10.1097/00001503-200010000-00013.
- Arnstein PM. The neuroplastic phenomenon: a physiologic link between chronic pain and learning. J Neurosci Nurs. 1997 Jun;29(3):179-86. doi: 10.1097/01376517-199706000-00005.
- Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
- Mercier C, Reilly KT, Vargas CD, Aballea A, Sirigu A. Mapping phantom movement representations in the motor cortex of amputees. Brain. 2006 Aug;129(Pt 8):2202-10. doi: 10.1093/brain/awl180. Epub 2006 Jul 14.
- MacIver K, Lloyd DM, Kelly S, Roberts N, Nurmikko T. Phantom limb pain, cortical reorganization and the therapeutic effect of mental imagery. Brain. 2008 Aug;131(Pt 8):2181-91. doi: 10.1093/brain/awn124. Epub 2008 Jun 20.
- Birbaumer N, Lutzenberger W, Montoya P, Larbig W, Unertl K, Topfner S, Grodd W, Taub E, Flor H. Effects of regional anesthesia on phantom limb pain are mirrored in changes in cortical reorganization. J Neurosci. 1997 Jul 15;17(14):5503-8. doi: 10.1523/JNEUROSCI.17-14-05503.1997.
- Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.
- Sterr A, Elbert, T, Rostroh B. Functional reorganization of human cerebral cortex and its perceptual concomitants. In: Fahle M, Poggio T. Terceptual Learning. MIT Press, 2002: 138.
- Jensen TS, Krebs B, Nielsen J, Rasmussen P. Phantom limb, phantom pain and stump pain in amputees during the first 6 months following limb amputation. Pain. 1983 Nov;17(3):243-256. doi: 10.1016/0304-3959(83)90097-0.
- Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. doi: 10.1016/j.pain.2004.09.012. No abstract available.
- Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.
- Cleeland CS, Nakamura Y, Mendoza TR, Edwards KR, Douglas J, Serlin RC. Dimensions of the impact of cancer pain in a four country sample: new information from multidimensional scaling. Pain. 1996 Oct;67(2-3):267-73. doi: 10.1016/0304-3959(96)03131-4.
- Fischer, J: United States Military Casualty Statistics: Operation Iraqi Freedom and Operation Enduring Freedom. Congressional Research Service. March 25, 2009
- Chan BL, Witt R, Charrow AP, Magee A, Howard R, Pasquina PF, Heilman KM, Tsao JW. Mirror therapy for phantom limb pain. N Engl J Med. 2007 Nov 22;357(21):2206-7. doi: 10.1056/NEJMc071927. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMCSD.2010.0007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Phantom Limb Pain
-
Shirley Ryan AbilityLabCoapt, LLCRecruitingLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Amputation | Phantom Limb Pain | Phantom Pain | Phantom Sensation | Lower Limb Amputation Knee | Lower Limb Amputation at Ankle (Injury) | Upper Limb Amputation at the Hand | Upper Limb Amputation at the Wrist | Upper... and other conditionsUnited States
-
Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Lower Limb Amputation | Phantom PainRussian Federation
-
VA Office of Research and DevelopmentRecruitingChronic Pain | Lower Limb Amputation | Phantom Pain | Upper Limb Amputation | Phantom Limb Pain After AmputationUnited States
-
Artur BiktimirovEnrolling by invitationAmputation | Phantom Limb Pain | Phantom PainRussian Federation
-
Centre d'Investigation Clinique et Technologique...CompletedAmputation | Phantom Pain Following Amputation of Lower LimbFrance
-
University of California, San DiegoCompletedPhantom Limb Pain | Residual Limb PainUnited States
-
University of California, San DiegoVarian Medical Systems; Epimed InternationalRecruitingAmputation, Traumatic | Phantom Limb Pain | Phantom Pain Following Amputation of Lower Limb | Amputation, SurgicalUnited States
-
Cairo UniversityActive, not recruitingPhantom Pain Following Amputation of Lower LimbEgypt
-
University of Alabama at BirminghamCompletedAmputation | Phantom Limb Pain | Residual Limb PainUnited States
-
SPR Therapeutics, Inc.United States Department of Defense; NDI Medical, LLCCompletedPhantom Limb Pain | Residual Limb Pain | Post-Amputation PainUnited States
Clinical Trials on Sham (Comparator) Plasma Ball
-
Stanford UniversityRecruitingTreatment Resistant Depression | Bipolar II Disorder, Most Recent Episode Major Depressive | Current Depressive EpisodeUnited States
-
Case Western Reserve UniversityHighland Instruments, Inc.Recruiting
-
Ward Photonics LLCCompletedFat ReductionUnited States
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.RecruitingParkinson DiseaseUnited States
-
NGM Biopharmaceuticals, IncCompletedGeographic AtrophyUnited States
-
Novartis PharmaceuticalsCompletedDiabetic Macular Edema | Macular Edema | Neovascular Age-related Macular Degeneration | Retinal Vein OcclusionsPuerto Rico, United States
-
National Institute of Neurological Disorders and...RecruitingFunctional Movement DisorderUnited States
-
Nanjing First Hospital, Nanjing Medical UniversityWithdrawnDiabetic Kidney DiseaseChina
-
University of North Carolina, Chapel HillCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedObsessive-Compulsive DisorderFrance