Virtual Reality Guided Imagery for Chronic Pain

NCT ID: NCT04849897

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2022-04-30

Brief Summary

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.

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.

Conditions

Complex Regional Pain Syndromes; Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Audio Only Guided Imagery

Intervention Type: OTHER

Audio Recordings of Guided Imagery via an iPAD

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.

Group Type: EXPERIMENTAL

Experimental: Virtual Reality Guided Imagery

Intervention Type: DEVICE

Platform and VR Goggles

Interventions

Experimental: Virtual Reality Guided Imagery

Platform and VR Goggles

Intervention Type: DEVICE

Active Comparator: Audio Only Guided Imagery

Audio Recordings of Guided Imagery via an iPAD

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limbix Health, Inc.

INDUSTRY

Sponsor Role: collaborator

BehaVR LLC

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Steven Richeimer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Richeimer, MD

Role: PRINCIPAL_INVESTIGATOR

Keck School of Medicine, Dept. of Anesthesiology

Locations

USC Pain Center, Keck School of Medicine

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HS 1900549

Identifier Type: -

Identifier Source: org_study_id