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Virtual Reality Treatment for Phantom Limb Pain

Primary Purpose

Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distractor and Lower limb VR
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Amputation Above Knee (Injury)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects will have undergone amputation of one leg (either above or below the knee) at least 4 months before the enrollment in the study;
  • Will have chronic pain in the phantom limb:

Exclusion Criteria:

  • History of stroke or traumatic brain injury;
  • Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the PI on the study, who is a behavioral neurologist;
  • Subjects with major medical illness that would be expected to interfere with their ability to complete the study will be excluded.
  • Subjects with implanted electronic devices.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Distractor and Lower limb VR

Arm Description

The training sessions consist of Phase 1 (Distractor VR) in which patients will explore VR environments and Phase 2 (Lower limb VR) in which they will play games using their VR lower-limbs.

Outcomes

Primary Outcome Measures

Changes in the Brief Pain Inventory
The Brief Pain Inventory is a questionnaire which provide a description of the type and location of pain (question 1-2),the pain severity (question 3-6 pain rating scales with 0-10 range - with 10 indicating severe pain), of the current treatment for pain (question 7-8) and the pain interference in daily life (question 9- range from 0 to 10 with a maximum score of 10 indicating severe interference). A decrease (i.e. reduction in the scores) in pain severity and in the pain interference in daily activity is expected as consequence of the virtual reality training.
Changes in the McGill Pain Questionnaire
The McGill Pain Questionnaire is a questionnaire which provide a description of the type of pain using series of adjectives on of the pain severity, using a visual analogue scale (range of 0-100 range - with 100 indicating severe pain). A decrease in pain severity (decrease in the score in the visual analogue scale) is expected as consequence of the virtual reality training.
Changes in the Frenchay Activities Index
The the Frenchay Activities Index is a 15 items questionnaire, which investigate how often people perform certain daily activity (e.g. preparing meals), using a scale from 0 to 3, with a score of 3 indicating that the activity is performed frequently. An increase in the Frenchay Activities Index is expected as consequence of the virtual reality training.
Changes in the12-Item Short Form Health Survey
The12-Item Short Form Health Survey is a questionnaire which investigate the quality of emotional and physical heath of individuals. An improvement in the quality of the individuals' health is expected as consequence of the training.
Changes in the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale measures depression is a 14 questions scale, which measure the level of depression and anxiety (maximum score of 21 indicating abnormal performance). A decrease in the score in this scale is expected as consequence of the virtual reality training

Secondary Outcome Measures

Changes in the Limb deficiency and Phantom Limb questionnaire.
The Limb Deficiency and Phantom Limb questionnaire investigate qualitatively the phantom limb sensations.A reduction in the reported phantom limb sensation is expected as consequence of the virtual reality training
Changes in the 13-item Pain Catastrophizing scale
The 13-item Pain Catastrophizing scale assesses the level of negative thoughts and feeling associated with pain using a scale from 0-4 (score of 4 indicating highest frequency; maximum overall score 52). A reduction of the overall score is expected after the virtual reality training

Full Information

First Posted
November 1, 2017
Last Updated
June 15, 2020
Sponsor
University of Pennsylvania
Collaborators
Moss Rehabilitation Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03338842
Brief Title
Virtual Reality Treatment for Phantom Limb Pain
Official Title
Virtual Reality Treatment for Phantom Limb Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Moss Rehabilitation Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP). This study will test the use of virtual reality (VR) training as a possible treatment of PLP.
Detailed Description
Approximately 90% of patients with limb amputations experience the persistent sensation of the missing extremity, a phenomenon known as phantom limb (PL). Most patients with PL also experience a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).PLP is often attributed to a disruption of the primary sensory-motor representation, generating "noise" in the representation of the missing extremity, manifesting as pain. If loss of sensory feedback causes degradation of the these cortices, interventions that provide visual feedback about the missing extremity might fine-tune the primary sensory-motor cortices, thereby reducing pain. Within this framework, the present study explores the use of virtual reality (VR) training as a possible treatment of PLP. Twenty-five subjects with lower-limb amputation and chronic PLP will undergo a Virtual Reality (VR) treatment (17 one-hour sessions) consisting in two phases: a Distraction VR phase (5-7 sessions) in which they will explore VR environments using a joystick and a Lower-Limb VR treatment phase (10-12 sessions) in which they will participate in a variety of games and activities using their VR lower-limbs. A comprehensive battery for the assessment of the characteristics, intensity and the daily-life implication of PLP will be presented before and after the treatment and in three follow up testing sessions (1,4, 8 weeks). Furthermore, pain intensity will be assessed before and after each VR session. A dramatic reduction of PLP is expected after the VR treatment and that these beneficial effects remain stable in time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Below Knee (Injury), Phantom Limb Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distractor and Lower limb VR
Arm Type
Experimental
Arm Description
The training sessions consist of Phase 1 (Distractor VR) in which patients will explore VR environments and Phase 2 (Lower limb VR) in which they will play games using their VR lower-limbs.
Intervention Type
Device
Intervention Name(s)
Distractor and Lower limb VR
Intervention Description
In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.
Primary Outcome Measure Information:
Title
Changes in the Brief Pain Inventory
Description
The Brief Pain Inventory is a questionnaire which provide a description of the type and location of pain (question 1-2),the pain severity (question 3-6 pain rating scales with 0-10 range - with 10 indicating severe pain), of the current treatment for pain (question 7-8) and the pain interference in daily life (question 9- range from 0 to 10 with a maximum score of 10 indicating severe interference). A decrease (i.e. reduction in the scores) in pain severity and in the pain interference in daily activity is expected as consequence of the virtual reality training.
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Title
Changes in the McGill Pain Questionnaire
Description
The McGill Pain Questionnaire is a questionnaire which provide a description of the type of pain using series of adjectives on of the pain severity, using a visual analogue scale (range of 0-100 range - with 100 indicating severe pain). A decrease in pain severity (decrease in the score in the visual analogue scale) is expected as consequence of the virtual reality training.
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Title
Changes in the Frenchay Activities Index
Description
The the Frenchay Activities Index is a 15 items questionnaire, which investigate how often people perform certain daily activity (e.g. preparing meals), using a scale from 0 to 3, with a score of 3 indicating that the activity is performed frequently. An increase in the Frenchay Activities Index is expected as consequence of the virtual reality training.
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Title
Changes in the12-Item Short Form Health Survey
Description
The12-Item Short Form Health Survey is a questionnaire which investigate the quality of emotional and physical heath of individuals. An improvement in the quality of the individuals' health is expected as consequence of the training.
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Title
Changes in the Hospital Anxiety and Depression Scale
Description
The Hospital Anxiety and Depression Scale measures depression is a 14 questions scale, which measure the level of depression and anxiety (maximum score of 21 indicating abnormal performance). A decrease in the score in this scale is expected as consequence of the virtual reality training
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Secondary Outcome Measure Information:
Title
Changes in the Limb deficiency and Phantom Limb questionnaire.
Description
The Limb Deficiency and Phantom Limb questionnaire investigate qualitatively the phantom limb sensations.A reduction in the reported phantom limb sensation is expected as consequence of the virtual reality training
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Title
Changes in the 13-item Pain Catastrophizing scale
Description
The 13-item Pain Catastrophizing scale assesses the level of negative thoughts and feeling associated with pain using a scale from 0-4 (score of 4 indicating highest frequency; maximum overall score 52). A reduction of the overall score is expected after the virtual reality training
Time Frame
Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects will have undergone amputation of one leg (either above or below the knee) at least 4 months before the enrollment in the study; Will have chronic pain in the phantom limb: Exclusion Criteria: History of stroke or traumatic brain injury; Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the PI on the study, who is a behavioral neurologist; Subjects with major medical illness that would be expected to interfere with their ability to complete the study will be excluded. Subjects with implanted electronic devices.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Branch Coslett
Organizational Affiliation
hbc@mail.med.upenn.edu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurel Buxbaum
Organizational Affiliation
Lbuxbaum@einstein.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20827116
Citation
Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.
Results Reference
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PubMed Identifier
22085692
Citation
Dietrich C, Walter-Walsh K, Preissler S, Hofmann GO, Witte OW, Miltner WH, Weiss T. Sensory feedback prosthesis reduces phantom limb pain: proof of a principle. Neurosci Lett. 2012 Jan 24;507(2):97-100. doi: 10.1016/j.neulet.2011.10.068. Epub 2011 Nov 7.
Results Reference
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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
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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
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PubMed Identifier
3670870
Citation
Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
Results Reference
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PubMed Identifier
6869117
Citation
Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
Results Reference
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PubMed Identifier
8628042
Citation
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
Results Reference
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PubMed Identifier
6880820
Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Results Reference
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PubMed Identifier
22981809
Citation
Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
Results Reference
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Virtual Reality Treatment for Phantom Limb Pain

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