Clinical trial NCT04849897: Virtual Reality Guided Imagery for Chronic Pain
Official title: Virtual Reality Guided Imagery for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Back Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Limbix Health, Inc.
name: BehaVR LLC
First posted: 2021-04-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log
timeFrame: Baseline
measure: Number of Enrolled Participants Who do Not Complete the Study as Documented in Log
timeFrame: Baseline to 2 week follow up
measure: Number of Practice Sessions Completed by Participants as Documented in Spread Sheet
timeFrame: Baseline to 2 week follow up
measure: Pain Assessed by Pain Numeric Rating Scale
timeFrame: Baseline to 2 week follow up
measure: Opioid Medication Usage Assessed by Frequency of Use Log
timeFrame: Baseline to 2 week follow up
measure: Non-opioid Pain Medication Usage Assessed by Frequency of Use Log
timeFrame: Baseline to 2 week follow up
Secondary outcomes:
measure: Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
timeFrame: Baseline to 2 week follow up
measure: Depression Assessed by the Patient Health Questionnaire PHQ-2
timeFrame: Baseline to 2 week follow up
measure: Short Form Health Survey (SF12v12)
timeFrame: Baseline to 2 week follow up
measure: Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
timeFrame: Baseline to 2 week follow up
measure: Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion
timeFrame: Baseline to 2 week follow up
measure: Daily Pain Numerical Rating Scale
timeFrame: Baseline to 2 week follow up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Pain Center, Keck School of Medicine
state: California
Study officials:
affiliation: Keck School of Medicine, Dept. of Anesthesiology
name: Steven Richeimer, MD
role: PRINCIPAL_INVESTIGATOR
References: