Immersive Virtual Reality for Neuropathic Pain

Management of Pain in Limb Neuropathic Conditions Through Immersive Virtual Reality

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.

Study Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndromes; Neuropathic Pain; Neuropathy; Phantom Limb Pain
• Intervention / Treatment: Other: Immersive Virtual Reality

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Health, East Campus Outpatient Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Limb neuropathic conditions; Includes phantom limb pain, complex regional pain syndrome	Other: Immersive Virtual Reality; Participants will engage in virtual visualization therapy in an immersive virtual reality environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately following final virtual reality session
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.	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
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.	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
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.	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Brian Chau, MD, Loma Linda Univeristy

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2016
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (ACTUAL): June 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neurobehavioral Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Perceptual Disorders; Pain, Postoperative; Neuralgia; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Phantom Limb
• Other Study ID Numbers: 5150437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No