Virtual Reality Guided Imagery for Chronic Pain

Not Applicable

Completed

Conditions: Back Pain
Complex Regional Pain Syndromes

Registration Number: NCT04849897

Lead Sponsor: University of Southern California

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 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
Opioid 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.
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log	Baseline to 2 week follow up	Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
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.

Secondary Outcome Measures

Name	Time	Method
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 0-6 with higher number indicating worse anxiety outcome.
Depression Assessed by the Patient Health Questionnaire PHQ-2	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 6 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 has two composite scores (Physical composite score and Mental composite score). Each score has a range of 0 to 100 with higher scores indicating better health outcomes.
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
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, 0-8, higher score indicate worse symptom outcome.
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. Scale is 0-50.