An interventional study of Experimental: Virtual Reality Guided Imagery and Active Comparator: Audio Only Guided Imagery in Complex Regional Pain Syndromes and Back Pain, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 88 studies in Complex Regional Pain Syndromes with a site in United States — 20 open to participants now, 22 under way, 2 of them phase 3. Complex Regional Pain Syndromes · United States.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, this one is the 29th largest by enrollment of the 67 interventional ones that give a count, is one of 2 that started in 2021, is one of 36 with no phase, and was the 61st registered.
206 studies on the registry are indexed under Complex Regional Pain Syndromes; 54 are open to participants now.
Browse Complex Regional Pain Syndromes studies →20 of the 88 studies in Complex Regional Pain Syndromes with a site in United States are open now. Recruiting first, the newest first:
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
The Cleveland Clinic · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Ambros Therapeutics, Inc. · Sites in United States
Ages 18+
Scripps Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Complex Regional Pain Syndromes studies recruiting now, 17 (44%) set no upper age limit and 16 (41%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 10 · Phase 3 13 · Phase 4 4
First in 2000; this study’s year is marked. 2 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is close to the median of 40 across 152 interventional studies indexed under Complex Regional Pain Syndromes.
Median enrollment 30 across the 67 interventional studies, 60 across the 21 observational. Of the 56 that completed or were terminated, 29 (52%) have results posted.
This tab as a report to print or save as PDF → With an account.
20 of 88 have an industry lead sponsor. The 10 most frequent:
University of Southern California is the lead sponsor of 792 studies on the registry; 137 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
University of Southern California has 2 studies filed under Complex Regional Pain Syndromes — fewer than ten, so there is no comparison to draw.
8 of the studies in Complex Regional Pain Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06798493Hospital for Special Surgery, New YorkCSS-SR Validation Study | 2026-12-29 |
| NCT05593237University of California, San FranciscoTranscranial Magnetic Stimulation for Chronic Neuropathic Pain | 2026-12-30 |
| NCT05477004Theresa LiiObservational Study of Ketamine Infusions for the Treatment of Chronic Pain | 2026-12-31 |
| NCT05777889Hospital for Special Surgery, New YorkInfrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients | 2027-02 |
| NCT05814497Children's Hospital Medical Center, CincinnatiSupraspinal Processing of Sensory Aspects of Pain | 2027-06-30 |
Add all 8 to your calendar (.ics) → With an account.
Among the 88 studies in Complex Regional Pain Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
○ 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Active Comparator: Audio Only Guided Imagery
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.
Device: Experimental: Virtual Reality Guided Imagery
Platform and VR Goggles
Audio Recordings of Guided Imagery via an iPAD
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline to 2 week follow up
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline to 2 week follow up
| Milestone | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Started | 24 | 12 |
| Completed | 21 | 11 |
| Not completed | 3 | 1 |
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
| Participants | Total Recruited |
|---|---|
| Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log | 60 |
Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
| Participants | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Number of Enrolled Participants Who do Not Complete the Study as Documented in Log | 3 | 1 |
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
| Daily ratings completed | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Number of Practice Sessions Completed by Participants as Documented in Spread Sheet | 10.8 ± 3.58 | 11.4 ± 4.27 |
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.
| units on a scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in Lowest Score Follow up Baseline | 0.381 ± 1.36 | 0.091 ± 1.04 |
| Lowest Score Baseline | 4 ± 1.82 | 3.92 ± 1.51 |
| Lowest Score Follow up | 3.71 ± 1.95 | 3.64 ± 1.63 |
| Change in Highest Score Follow-up-Baseline | 0.619 ± .973 | 0.100 ± 1.37 |
| Highest Score Baseline | 8.42 ± 0.83 | 7.75 ± 1.36 |
| Highest Score Follow-up | 7.86 ± 1.01 | 7.4 ± 0.97 |
| Change in Average Score Follow-up-baseline | 0.524 ± 1.08 | 0.182 ± 1.08 |
| Average Score Baseline | 6.08 ± 1.18 | 5.75 ± 1.42 |
| Average Score Follow-up | 5.62 ± 1.5 | 5.46 ± 1.44 |
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
| Count of Participants with Reduced Opioi | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Opioid Medication Usage Assessed by Frequency of Use Log | 0 | 1 |
Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
| Pt. count reduced non-opoid pain med use | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Non-opioid Pain Medication Usage Assessed by Frequency of Use Log | 6 | 3 |
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.
| score on GAD-2 scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in GAD (Follow up-Baseline | -1.2 ± 1.20 | -.06 ± 1.17 |
| GAD Baseline | 1.83 ± 1.86 | 1.58 ± 1.68 |
| GAD Follow-up | 0.9 ± 1.17 | 1.2 ± 1.55 |
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.
| score on PHQ-2 scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in PHQ (Follow up-Baseline) | -1.10 ± 1.34 | 0 ± 0.47 |
| PHQ Baseline | 2 ± 1.53 | 1.33 ± 1.44 |
| PHQ Follow-up | 0.86 ± 1.39 | 1.3 ± 1.7 |
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.
| score on SF 12 scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in Physical Score (Follow-up- Baseline) | 7.3 ± 6.42 | -1.85 ± 6.81 |
| Physical Score Baseline | 27.0 ± 6.87 | 29.1 ± 4.80 |
| Physical Score Follow up | 27.9 ± 8.61 | 27.7 ± 7.22 |
| Change in Mental Score (Follow-up - Baseline) | 6.56 ± 7.25 | 5.65 ± 7.89 |
| Mental Score Baseline | 43.6 ± 12.3 | 43.5 ± 13.1 |
| Mental Score Follow up | 50.4 ± 10.2 | 48.6 ± 16.2 |
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.
| score on Oswestry Disability scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in ODI (Follow-up - Baseline) | -3.44 ± 3.40 | -4.83 ± 7.65 |
| ODI Baseline | 24.6 ± 5.66 | 25.8 ± 8.98 |
| ODI Follow up | 20.8 ± 5.65 | 21 ± 9.07 |
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.
No measurements were reported for this outcome.
Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes
| difference score on pain scale | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| Change in Pain Score (Follow-up - Baseline) | -0.906 ± 0.851 | -.757 ± 0.489 |
| Pre Pain Score | 5.75 ± 1.5 | 5.49 ± 1.41 |
| Post pain Score | 4.82 ± 1.48 | 4.8 ± 1.47 |
Collected over 2 weeks. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Virtual Reality Guided Imagery (VR-GI) | 0/23 (0%) | 0/23 (0%) | 5/23 (21.7%) |
| Audio Only Guided Imagery (AO-GI) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Virtual Reality Guided Imagery (VR-GI) | Audio Only Guided Imagery (AO-GI) |
|---|---|---|
| device usageProduct Issues | 5/23 | 0/12 |
| Age, Customized(Participants) | Audio Only Guided Imagery (AO-GI) | Virtual Reality Guided Imagery (VR-GI) | Total |
|---|---|---|---|
| age greater than 18 | 12 | 24 | 36 |
| Sex: Female, Male(Participants) | Audio Only Guided Imagery (AO-GI) | Virtual Reality Guided Imagery (VR-GI) | Total |
|---|---|---|---|
| Female | 10 | 16 | 26 |
| Male | 2 | 8 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Audio Only Guided Imagery (AO-GI) | Virtual Reality Guided Imagery (VR-GI) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 11 | 19 | 30 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Audio Only Guided Imagery (AO-GI) | Virtual Reality Guided Imagery (VR-GI) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 9 | 18 | 27 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 1 | 4 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2021 to primary completion in Apr 2022, 13 months.
Results were first posted in Mar 2024, 1 year 10 months after primary completion.
Of 64 non-industry interventional studies with no phase under Complex Regional Pain Syndromes, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 13 months is below that.
Counting every sponsor, half of 65 studies reached it within 24 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Complex Regional Pain Syndromes →
University of Southern California →