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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
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 5, 2017
Last Updated
May 12, 2021
Sponsor
Loma Linda University
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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

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Immersive Virtual Reality for Neuropathic Pain

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