Virtual Reality for Phantom Limb Pain
Primary Purpose
Phantom Limb Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria:
- Ages 21-75 Veteran receiving care at VA San Diego Healthcare System
- Upper or lower extremity amputation with reported PLP for at least six months
- PLP intensity > 3/10
- English-speaking, literate, with stable residence
- Able to operate a VR headset as evidenced by direct observation
Exclusion Criteria:
Major medical illness that might confound effects of pain on function, e.g.:
- advanced cardiac
- pulmonary disease
- current active alcohol or substance use disorder as evidenced from medical record
- currently active suicidality
- homicidality, or unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
- moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
- prior mirror therapy experience
Sites / Locations
- VA San Diego Healthcare System, San Diego, CA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality
Arm Description
Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Outcomes
Primary Outcome Measures
Phantom Limb Pain Questionnaire (PLPQ)
The PLPQ assesses the severity of PLP, stump pain and phantom limb sensation. Severity is assessed on a standard 11-point Likert scale pain measure, range 0-10 with higher scores indicating greater PLP.
Secondary Outcome Measures
Full Information
NCT ID
NCT02784548
First Posted
May 24, 2016
Last Updated
September 9, 2019
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02784548
Brief Title
Virtual Reality for Phantom Limb Pain
Official Title
Adapting Virtual Reality Technology for the Treatment of Phantom Limb Pain
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will develop a virtual reality-based treatment for phantom limb pain among Veterans and test it against the most established behavioral therapy for phantom limb pain, mirror therapy.
Detailed Description
The VA system performs more than 10% of all amputations in the U.S., a percentage translating into more than 50,000 upper and lower extremity amputations in the past decade. Among Veterans with amputations, research suggests that upwards of 70% experience phantom limb pain (PLP), an often chronic and debilitating condition with adverse effects on quality of life and poor responsiveness to conventional pain treatments. The use of virtual reality technology for chronic pain management is a novel and rapidly advancing area of study, with existing research suggesting that virtual reality treatments are effective for acute pain management, promising for chronic pain management, and as yet untested for PLP. In the current study, the investigators will develop a virtual reality environment that simulates mirror therapy - the gold standard behavioral treatment for PLP - comparing the efficacy of this modality in a population of Veterans with PLP against a standard mirror therapy treatment validated by this research team in a previously supported clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Using a Virtual reality (VR) headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Intervention Type
Other
Intervention Name(s)
Virtual Reality
Intervention Description
Using a VR headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
Primary Outcome Measure Information:
Title
Phantom Limb Pain Questionnaire (PLPQ)
Description
The PLPQ assesses the severity of PLP, stump pain and phantom limb sensation. Severity is assessed on a standard 11-point Likert scale pain measure, range 0-10 with higher scores indicating greater PLP.
Time Frame
PLPQ scores before versus after initial use of the VR treatment in the laboratory
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 21-75 Veteran receiving care at VA San Diego Healthcare System
Upper or lower extremity amputation with reported PLP for at least six months
PLP intensity > 3/10
English-speaking, literate, with stable residence
Able to operate a VR headset as evidenced by direct observation
Exclusion Criteria:
Major medical illness that might confound effects of pain on function, e.g.:
advanced cardiac
pulmonary disease
current active alcohol or substance use disorder as evidenced from medical record
currently active suicidality
homicidality, or unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
prior mirror therapy experience
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R. Rutledge, PhD MA
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Virtual Reality for Phantom Limb Pain
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