Virtual Reality Guided Imagery for Chronic Pain (VRGI)

To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.

Study Overview

• Status: Completed
• Conditions: Back Pain; Complex Regional Pain Syndromes
• Intervention / Treatment: Other: Active Comparator: Audio Only Guided Imagery; Device: Experimental: Virtual Reality Guided Imagery

Detailed Description

○ Chronic pain affects over 100 million adults in the US, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560-635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15-26% risk of misuse and abuse among pain patients, highlighting a critical need to develop effective non-pharmacological interventions for pain. Guided imagery (GI), a cognitive-behavioral technique for guiding patients to create multisensory, imagined scenes to increase well-being, is an effective non-pharmacological intervention for reducing pain. However, its effectiveness is limited by patients' imaging abilities. The long-term objective of this project is to reduce chronic pain and opioid use by developing an at-home virtual reality (VR)-GI intervention to improve chronic pain management using the Limbix VR Kit. Given the enhanced immersiveness and interactivity of VR, VR-GI is expected to reduce pain and reliance on opioids, as well as improve functional outcomes and mood, compared to traditional audio-only GI and usual care. The specific aims are to evaluate feasibility and usability of an at-home VRGI intervention in a 2-week clinical trial. Two 15-min VR-GI experiences that guide patients through psychoeducation, relaxation exercises, and interactive virtual worlds that allow them to control their experience of pain will be evaluated. To assess feasibility of an at-home VR-GI intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview. This research directly addresses the need to improve pain treatment to prevent opioid use disorder.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Pain Center, Keck School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be a patient at the University of Southern California Pain Center
• - English Fluency
• Diagnosis of chronic back pain or complex regional pain syndrome
• Average pain intensity of 5 on a 0 to 10 scale for more than 3 month
• Access to a device with video and audio capability and sufficient WiFI to participate in on-line sessions

Exclusion Criteria:

• History of significant motion sickness
• Active nausea/vomiting
• Epilepsy
• Significant movement problems
• Significant vision or hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet; Listen to narrative scripts based on traditional GI audio recordings. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the GI experience.	Other: Active Comparator: Audio Only Guided Imagery; Audio Recordings of Guided Imagery via an iPAD
Experimental: Experimental: Virtual Reality Guided Imagery Platform and VR Headset; VR headset for guided imagery with audiovisual computer-generated VR content to accompany the GI narration. The narrative scripts will include psychoeducation content that explains how the mind and brain can influence physical pain and how they can be trained to effect changes in experienced chronic pain. Narration will guide users in breathing and relaxation exercises and explain how patients can continue to exert control over their pain outside of the VR-GI experience.	Device: Experimental: Virtual Reality Guided Imagery; Platform and VR Goggles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log	Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll	Baseline
Number of Enrolled Participants Who do Not Complete the Study as Documented in Log	Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.	Baseline to 2 week follow up
Number of Practice Sessions Completed by Participants as Documented in Spread Sheet	Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention	Baseline to 2 week follow up
Pain Assessed by Pain Numeric Rating Scale	Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes.	Baseline to 2 week follow up
Opioid Medication Usage Assessed by Frequency of Use Log	Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.	Baseline to 2 week follow up
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log	Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes	Baseline to 2 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Pain Numerical Rating Scale	Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes	Baseline to 2 week follow up
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)	Generalized Anxiety Disorder Assessment is calculated by assigning scores of 1,2,3 and 4, to the response categories of Not at all sure, Several Days,Over half the days, Nearly every day , respectively. Total score for the two ranges from 0-6 with higher number indicating worse anxiety outcome.	Baseline to 2 week follow up
Depression Assessed by the Patient Health Questionnaire PHQ-2	Patient Health Questionnaire is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of not at all, several days more than half the days, and-nearly every day, respectively. Total score for the two ranges from 0 to 6 with higher number worse depression outcome.	Baseline to 2 week follow up
Short Form Health Survey (SF12v12)	Health-related quality of life assessment Short Form Health Survey 12 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes.	Baseline to 2 week follow up
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)	Pain Management assessments for patients with back pain. Oswestry Disability Index For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5 with 50 as a highest score; higher scores indicating a worse disability outcome from back pain. Scale is 0-50.	Baseline to 2 week follow up
Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion	Pain management assessments for patients with CRPS. Complex Regional Pain Syndrome (CRPS) Severity Score (CSS-17) 0 absence of symptoms, 1 presence of symptoms, 0-8, higher score indicate worse symptom outcome.	Baseline to 2 week follow up

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Limbix Health, Inc.; BehaVR, Inc.
• Investigators: Principal Investigator: Steven Richeimer, MD, Keck School of Medicine, Dept. of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Chronic Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy
• Other Study ID Numbers: HS 1900549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No