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Perioperative Mirror Therapy and Phantom Limb Pain

Primary Purpose

Phantom Limb Pain, Phantom Pain, Phantom Sensation

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sham (Comparator) Plasma Ball
Mirror
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom limb pain, Mirror therapy, Elective amputation, Residual limb pain, Functional MRI

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

No Intervention

Arm Label

Plasma Ball (Control)

Experimental

Non-Surgical

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2015
Last Updated
August 26, 2019
Sponsor
United States Naval Medical Center, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02383979
Brief Title
Perioperative Mirror Therapy and Phantom Limb Pain
Official Title
Perioperative Visual Therapy May Help Prevent Phantom Limb Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Naval Medical Center, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Phantom Pain, Phantom Sensation, Pseudomelia
Keywords
Phantom limb pain, Mirror therapy, Elective amputation, Residual limb pain, Functional MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plasma Ball (Control)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Surgical
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sham (Comparator) Plasma Ball
Intervention Description
will consist of undergoing a sham therapy with a 22" plasma globe involving contralateral limb interaction with the sphere.
Intervention Type
Device
Intervention Name(s)
Mirror
Intervention Description
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 Information:
Title
Comparing fMRI scans to see if mirror therapy helps prevent or alleviate phantom limb pain in service members undergoing amputation(s)
Description
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.
Time Frame
4 weeks prior to surgery through 1 year post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Hanling, MD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Medicine Center, Department of Anesthesiology, Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lillian G Murray, MPH
Phone
619-804-7765
Email
lillian.g.murray2.ctr@mail.mil
First Name & Middle Initial & Last Name & Degree
Steven R Hanling, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17890346
Citation
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.
Results Reference
background
PubMed Identifier
9762952
Citation
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.
Results Reference
background
PubMed Identifier
17016358
Citation
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.
Results Reference
background
PubMed Identifier
9220365
Citation
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.
Results Reference
background
PubMed Identifier
8637922
Citation
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.
Results Reference
background
PubMed Identifier
16844715
Citation
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.
Results Reference
background
PubMed Identifier
18567624
Citation
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.
Results Reference
background
PubMed Identifier
9204932
Citation
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.
Results Reference
background
PubMed Identifier
10835434
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
6657285
Citation
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.
Results Reference
background
PubMed Identifier
15621359
Citation
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.
Results Reference
background
PubMed Identifier
11690728
Citation
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.
Results Reference
background
PubMed Identifier
8080219
Citation
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Results Reference
background
PubMed Identifier
8951920
Citation
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.
Results Reference
background
PubMed Identifier
13688369
Citation
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.
Results Reference
background
Citation
Fischer, J: United States Military Casualty Statistics: Operation Iraqi Freedom and Operation Enduring Freedom. Congressional Research Service. March 25, 2009
Results Reference
background
PubMed Identifier
18032777
Citation
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.
Results Reference
background

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Perioperative Mirror Therapy and Phantom Limb Pain

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