Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Reality Treatment for Phantom Limb Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338842
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
Moss Rehabilitation Research Institute
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE November 1, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE January 12, 2018
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Changes in the Brief Pain Inventory [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Changes in the Brief Pain Inventory [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The Brief Pain Inventory (Cleeland & Ryan, 1994) 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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The McGill Pain Questionnaire (Melzack et al., 1987) 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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The the Frenchay Activities Index (Holbrook & Skilbeck, 1983) 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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The12-Item Short Form Health Survey (Ware, Kosinski, & Keller, 1996) 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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Changes in the Limb deficiency and Phantom Limb questionnaire. [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
  • Changes in the Limb deficiency and Phantom Limb questionnaire. [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The Limb Deficiency and Phantom Limb questionnaire (Goller, 2011) 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 [ Time Frame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks ]
    The 13-item Pain Catastrophizing scale (Sullivan, Bishop, & Pivik, 1995) 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Treatment for Phantom Limb Pain
Official Title  ICMJE Virtual Reality Treatment for Phantom Limb Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Lower Limb Amputation Above Knee (Injury)
  • Lower Limb Amputation Below Knee (Injury)
  • Phantom Limb Pain
Intervention  ICMJE Device: Distractor and Lower limb VR
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.
Study Arms  ICMJE Experimental: Distractor and Lower limb VR
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: Device: Distractor and Lower limb VR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2017)
30
Actual Study Completion Date  ICMJE November 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03338842
Other Study ID Numbers  ICMJE 823287
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Moss Rehabilitation Research Institute
Investigators  ICMJE
Principal Investigator: Branch Coslett hbc@mail.med.upenn.edu
Principal Investigator: Laurel Buxbaum Lbuxbaum@einstein.edu
PRS Account University of Pennsylvania
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP