search
Back to results

Virtual Reality Guided Imagery for Chronic Pain (VRGI)

Primary Purpose

Complex Regional Pain Syndromes, Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Virtual Reality Guided Imagery
Active Comparator: Audio Only Guided Imagery
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC Pain Center, Keck School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet

Experimental: Virtual Reality Guided Imagery Platform and VR Headset

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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
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.
Medication Usage assessed by frequency of use log
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)
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)
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)
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)
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
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
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes

Full Information

First Posted
April 9, 2021
Last Updated
May 6, 2022
Sponsor
University of Southern California
Collaborators
Limbix Health, Inc., BehaVR, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04849897
Brief Title
Virtual Reality Guided Imagery for Chronic Pain
Acronym
VRGI
Official Title
Virtual Reality Guided Imagery for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Limbix Health, Inc., BehaVR, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes, Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental: Virtual Reality Guided Imagery Platform and VR Headset
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Experimental: Virtual Reality Guided Imagery
Intervention Description
Platform and VR Goggles
Intervention Type
Other
Intervention Name(s)
Active Comparator: Audio Only Guided Imagery
Intervention Description
Audio Recordings of Guided Imagery via an iPAD
Primary Outcome Measure Information:
Title
Incidence of participants who are recruited but not enrolled as documented in participant log
Description
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
Time Frame
Baseline
Title
Number of enrolled participants who do not complete the study as documented in log
Description
Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
Time Frame
Baseline to 2 week follow up
Title
Number of practice sessions completed by participants as documented in spread sheet
Description
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
Time Frame
Baseline to 2 week follow up
Title
Pain assessed by Pain Numeric Rating Scale
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Medication Usage assessed by frequency of use log
Description
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Time Frame
Baseline to 2 week follow up
Secondary Outcome Measure Information:
Title
Anxiety assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Depression assessed by the Patient Health Questionnaire PHQ-2 (PHQ-9)
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Short Form Health Survey (SF12v12)
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Complex Regional Pain Syndrome Symptoms assessed by the CSS 17 patientobservation portion
Description
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.
Time Frame
Baseline to 2 week follow up
Title
Daily Pain Numerical Rating Scale
Description
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes
Time Frame
Baseline to 2 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Richeimer, MD
Organizational Affiliation
Keck School of Medicine, Dept. of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Pain Center, Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality Guided Imagery for Chronic Pain

We'll reach out to this number within 24 hrs