Virtual Reality Guided Imagery for Chronic Pain

NCT04849897 | Completed Results FDA Device

• 1 other identifier: HS 1900549
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Complex Regional Pain Syndromes; Back Pain

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)

  Baseline to 2 week follow up

• Depression Assessed by the Patient Health Questionnaire PHQ-2

  Baseline to 2 week follow up

• Short Form Health Survey (SF12v12)

  Baseline to 2 week follow up

• Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)

  Baseline to 2 week follow up

• Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion

  Baseline to 2 week follow up

Study Arms (2)

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

ACTIVE COMPARATOR

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

Experimental: Virtual Reality Guided Imagery Platform and VR Headset

EXPERIMENTAL

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

Interventions

Experimental: Virtual Reality Guided Imagery DEVICE

Platform and VR Goggles

Experimental: Virtual Reality Guided Imagery Platform and VR Headset

Active Comparator: Audio Only Guided Imagery OTHER

Audio Recordings of Guided Imagery via an iPAD

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• Limbix Health, Inc.: collaborator
• BehaVR LLC: collaborator

Study Sites (1)

USC Pain Center, Keck School of Medicine

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Back Pain

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Steven Richeimer
• Organization: University of Southern California

steven.richeimer@med.usc.edu

323-442-6202

Study Officials

• Steven Richeimer, MD

  Keck School of Medicine, Dept. of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 19, 2021
• Study Start: March 22, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 21, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)