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OpenTrials
Completed

NCT Number: NCT04849897

Virtual Reality Guided Imagery for Chronic Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Pain Center, Keck School of Medicine

Los Angeles, California, 90033, United States

About this study

○ 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Virtual Reality Guided Imagery

Device

Platform and VR Goggles

Active Comparator: Audio Only Guided Imagery

Other

Audio Recordings of Guided Imagery via an iPAD

Primary outcomes

  1. Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log

    Time frame: Baseline

    Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll

  2. Number of Enrolled Participants Who do Not Complete the Study as Documented in Log

    Time frame: 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.

  3. Number of Practice Sessions Completed by Participants as Documented in Spread Sheet

    Time frame: Baseline to 2 week follow up

    Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention

  4. Pain Assessed by Pain Numeric Rating Scale

    Time frame: 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.

  5. Opioid Medication Usage Assessed by Frequency of Use Log

    Time frame: Baseline to 2 week follow up

    Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.

  6. Non-opioid Pain Medication Usage Assessed by Frequency of Use Log

    Time frame: 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

Secondary outcomes

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

    Time frame: 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.

  2. Depression Assessed by the Patient Health Questionnaire PHQ-2

    Time frame: 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.

  3. Short Form Health Survey (SF12v12)

    Time frame: 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.

  4. Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)

    Time frame: 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.

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

    Time frame: 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.

  6. Daily Pain Numerical Rating Scale

    Time frame: Baseline to 2 week follow up

    Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • BehaVR LLC
  • Limbix Health, Inc.

Registry information

Acronym: VRGI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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