Immersive Virtual Reality for Neuropathic Pain
Primary Purpose
Neuropathy, Phantom Limb Pain, Complex Regional Pain Syndromes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immersive Virtual Reality
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb
Exclusion Criteria:
- Cognitive impairment leading to inability to make own medical decisions
- Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
- History of seizures within the last year
Sites / Locations
- Loma Linda University Health, East Campus Outpatient Rehabilitation Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Limb neuropathic conditions
Arm Description
Includes phantom limb pain, complex regional pain syndrome
Outcomes
Primary Outcome Measures
Feasibility of Virtual Reality Environment Use Questionnaire
Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.
Pain Relief with Virtual Reality Therapy: Wong-Baker Scale
Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Pain Relief with Virtual Reality Therapy: Visual Analog Scale
Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale
Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03203772
Brief Title
Immersive Virtual Reality for Neuropathic Pain
Official Title
Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 14, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Investigating how neuropathic limb pain, including phantom limb pain or complex regional pain syndrome, is affected by virtual reality. While several studies have looked into virtual reality for treating this type of pain, few have used the latest immersive virtual reality hardware combined with motion control for an engaging virtual mirror therapy experience. The investigators are interested in studying the use of virtual reality as an alternative treatment option for these conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy, Phantom Limb Pain, Complex Regional Pain Syndromes, Neuropathic 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
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Limb neuropathic conditions
Arm Type
Experimental
Arm Description
Includes phantom limb pain, complex regional pain syndrome
Intervention Type
Other
Intervention Name(s)
Immersive Virtual Reality
Intervention Description
Participants will engage in virtual visualization therapy in an immersive virtual reality environment
Primary Outcome Measure Information:
Title
Feasibility of Virtual Reality Environment Use Questionnaire
Description
Using a questionnaire, feedback over participant self-reported tolerance of the virtual reality environment, participant likelihood of recommending this therapy to others with similar conditions, reported sense of presence in presented scenario(s), comfort of virtual reality devices, impact on self-reported functional ability outside of clinic, and overall impression of virtual reality therapy will be recorded.
Time Frame
Immediately following final virtual reality session
Title
Pain Relief with Virtual Reality Therapy: Wong-Baker Scale
Description
Change in Wong-Baker Faces pain scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Time Frame
Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Title
Pain Relief with Virtual Reality Therapy: Visual Analog Scale
Description
Change in Visual Analog Pain Scale will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Time Frame
Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
Title
Pain Relief with Virtual Reality Therapy: Short-Form McGill Pain Scale
Description
Change in Short-Form McGill Pain Questionnaire will be measured. This will be done by obtaining pain scale scores immediately prior to therapy session, immediately following therapy, and several weeks post last therapy session.
Time Frame
Change from initial scores prior to virtual reality exposure to immediately prior to and following virtual reality sessions, and up to 8 weeks following last sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of complex regional pain syndrome or phantom limb pain in an upper or lower limb
Exclusion Criteria:
Cognitive impairment leading to inability to make own medical decisions
Complete inability to utilize leg or arm muscles that are needed for motion controller tracking
History of seizures within the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Chau, MD
Organizational Affiliation
Loma Linda Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health, East Campus Outpatient Rehabilitation Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immersive Virtual Reality for Neuropathic Pain
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