Virtual Reality Guided Imagery for Chronic Pain (VRGI)

University of Southern California

Status: Completed

Conditions: Complex Regional Pain Syndromes; Back Pain

Treatments: Other: Active Comparator: Audio Only Guided Imagery; Device: Experimental: Virtual Reality Guided Imagery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04849897

HS 1900549

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet

Active Comparator group

Description:

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.

Treatment:

Other: Active Comparator: Audio Only Guided Imagery

Experimental: Virtual Reality Guided Imagery Platform and VR Headset

Experimental group

Description:

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.

Treatment:

Device: Experimental: Virtual Reality Guided Imagery