Complex Regional Pain SyndromesVRGINCT04849897
Virtual Reality Guided Imagery for Chronic Pain
A study testing Experimental: Virtual Reality Guided Imagery and Active Comparator: Audio Only Guided Imagery in people with Complex Regional Pain Syndromes and Back Pain, run by University of Southern California at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndromes, Back Pain
- What is being tested?
- Experimental: Virtual Reality Guided Imagery and Active Comparator: Audio Only Guided Imagery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of significant motion sickness
- Active nausea/vomiting
- Epilepsy
- Significant movement problems
- Significant vision or hearing impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Pain Center, Keck School of Medicine
Los Angeles, California, 90033
About this study
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.
Read the 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.
- Conditions
- Complex Regional Pain Syndromes, Back Pain
- Being tested
- Experimental: Virtual Reality Guided Imagery, Active Comparator: Audio Only Guided Imagery
- Medical subject headings
- Complex Regional Pain Syndromes, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Virtual Reality Guided ImageryDevice
Platform and VR Goggles
Active Comparator: Audio Only Guided ImageryOther
Audio Recordings of Guided Imagery via an iPAD
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet | Active comparator | 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. Receives: Other: Active Comparator: Audio Only Guided Imagery |
| Experimental: Virtual Reality Guided Imagery Platform and VR Headset | Experimental | 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. Receives: Device: Experimental: Virtual Reality Guided Imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to 2 week follow up
Opioid Medication Usage Assessed by Frequency of Use Log
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Measured: Baseline to 2 week follow up
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log
Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
Measured: Baseline to 2 week follow up
Secondary outcomes (6)
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 0-6 with higher number indicating worse anxiety outcome.
Measured: Baseline to 2 week follow up
Depression Assessed by the Patient Health Questionnaire PHQ-2
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.
Measured: Baseline to 2 week follow up
Short Form Health Survey (SF12v12)
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.
Measured: 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. Scale is 0-50.
Measured: 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, 0-8, higher score indicate worse symptom outcome.
Measured: 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
Measured: Baseline to 2 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start22 Mar 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Complex Regional Pain SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Limbix Health, Inc., BehaVR LLC
- Responsible party
- Principal investigator, Steven Richeimer, University of Southern California
- Investigators
- Steven Richeimer, MD, Principal investigator, Keck School of Medicine, Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849897
- Sponsor's protocol ID
- HS 1900549
- Acronym
- VRGI
- Status last verified
- Jul 2024
- First submitted
- 9 Apr 2021
- Last updated
- 21 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Guided Imagery for Chronic Pain
- ClinicalTrials.gov ID
- NCT04849897
- Acronym / sponsor ID
- VRGI / HS 1900549
- Conditions
- Complex Regional Pain Syndromes, Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Limbix Health, Inc., BehaVR LLC
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet | Active comparator | Other: Active Comparator: Audio Only Guided ImageryListen 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. |
| Experimental: Virtual Reality Guided Imagery Platform and VR Headset | Experimental | Device: Experimental: Virtual Reality Guided ImageryVR 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- History of significant motion sickness
- Active nausea/vomiting
- Epilepsy
- Significant movement problems
- Significant vision or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Virtual Reality Guided ImageryPlatform and VR Goggles | Device | Experimental: Virtual Reality Guided Imagery Platform and VR Headset |
| Active Comparator: Audio Only Guided ImageryAudio Recordings of Guided Imagery via an iPAD | Other | Active Comparator: Audio Only Guided Imagery Audio Recordings of Guided Imagery via tablet |
Primary outcome
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
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.
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
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.
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.
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
6 secondary outcomes
Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)
Time frame: Baseline to 2 week follow up
Depression Assessed by the Patient Health Questionnaire PHQ-2
Time frame: Baseline to 2 week follow up
Short Form Health Survey (SF12v12)
Time frame: Baseline to 2 week follow up
Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)
Time frame: Baseline to 2 week follow up
Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion
Time frame: Baseline to 2 week follow up
Daily Pain Numerical Rating Scale
Time frame: Baseline to 2 week follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Richeimer, MD principal investigator
Keck School of Medicine, Dept. of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Virtual Reality Guided Imagery and Active Comparator: Audio Only Guided Imagery in people with Complex Regional Pain Syndromes and Back Pain, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.