Virtual Reality Guided Imagery for Chronic Pain

Study Overview
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Brief Summary
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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
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○ 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.

Official Title
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Virtual Reality Guided Imagery for Chronic Pain

Conditions
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Complex Regional Pain Syndromes, Back Pain

Intervention / Treatment
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* Device: Experimental: Virtual Reality Guided Imagery
* Other: Active Comparator: Audio Only Guided Imagery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet<br>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<br>* Audio Recordings of Guided Imagery via an iPAD<br>|
| Experimental: Experimental: Virtual Reality Guided Imagery Platform and VR Headset<br>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<br>* Platform and VR Goggles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 7 to 28 with higher number indicating worse anxiety outcome. | Baseline to 2 week follow up | 
| Depression assessed by the Patient Health Questionnaire PHQ-2 (PHQ-9) | 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. | Baseline to 2 week follow up | 
| Short Form Health Survey (SF12v12) | 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. | 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. | 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, 0-10, higher score indicate worse symptom outcome. | Baseline to 2 week follow up | 
| 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 |