VRGI: Virtual Reality Guided Imagery for Chronic Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of participants who are recruited but not enrolled as documented in participant log [Baseline]
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
- Number of enrolled participants who do not complete the study as documented in log [Baseline to 2 week follow up]
Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
- Number of practice sessions completed by participants as documented in spread sheet [Baseline to 2 week follow up]
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
- Pain assessed by Pain Numeric Rating Scale [Baseline to 2 week follow up]
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.
- Medication Usage assessed by frequency of use log [Baseline to 2 week follow up]
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Secondary Outcome Measures
- Anxiety assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7) [Baseline to 2 week follow up]
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 7 to 28 with higher number indicating worse anxiety outcome.
- Depression assessed by the Patient Health Questionnaire PHQ-2 (PHQ-9) [Baseline to 2 week follow up]
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 27 with higher number worse depression outcome.
- Short Form Health Survey (SF12v12) [Baseline to 2 week follow up]
Health-related quality of life assessment.Short Form Health Survey 12 12 questions measuring physical and mental health. Responses are weighted to have a mean of 50. Scores above 50 indicate better health outcomes.
- Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI) [Baseline to 2 week follow up]
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.
- Complex Regional Pain Syndrome Symptoms assessed by the CSS 17 patientobservation portion [Baseline to 2 week follow up]
Pain management assessments for patients with CRPS. Complex Regional Pain Syndrome (CRPS) Severity Score (CSS-17) 0 absence of symptoms, 1 presence of symptoms, 0-10, higher score indicate worse symptom outcome.
- Daily Pain Numerical Rating Scale [Baseline to 2 week follow up]
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | USC Pain Center, Keck School of Medicine | Los Angeles | California | United States | 90033 |
Sponsors and Collaborators
- University of Southern California
- Limbix Health, Inc.
- BehaVR, Inc.
Investigators
- Principal Investigator: Steven Richeimer, MD, Keck School of Medicine, Dept. of Anesthesiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS 1900549