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| Name | Class |
|---|---|
| Limbix Health, Inc. | INDUSTRY |
| BehaVR LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Virtual Reality Guided Imagery | Device | Platform and VR Goggles |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | 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. | 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 | Baseline to 2 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2 week follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Richeimer, MD | Keck School of Medicine, Dept. of Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Pain Center, Keck School of Medicine | Los Angeles | California | 90033 | United States |
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96 applicants were recruited, 81 met inclusion criteria. 36 participants were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Virtual Reality Guided Imagery (VR-GI) | 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. |
| FG001 | Audio Only Guided Imagery (AO-GI) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Audio Only Guided Imagery (AO-GI) | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | Baseline |
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2 weeks
For the VR-GI group, adverse events were calculated with 23 participants as one participant did not receive allocated intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Virtual Reality Guided Imagery (VR-GI) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| device usage | Product Issues | Non-systematic Assessment | difficulty using device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Richeimer | University of Southern California | 323-442-6202 | steven.richeimer@med.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2024 | Feb 27, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Active Comparator: Audio Only Guided Imagery | Other | Audio Recordings of Guided Imagery via an iPAD |
|
| 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. | 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. | 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. | 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. | 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 | Baseline to 2 week follow up |
| BG001 | Virtual Reality Guided Imagery (VR-GI) | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | binary | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline to 2 week follow up |
|
|
|
| Primary | 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 | For the VR-Gi group, 23 participants were analyzed as one participant did not receive allocated intervention. | Posted | Mean | Standard Deviation | Daily ratings completed | Baseline to 2 week follow up |
|
|
|
| Primary | 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. | For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 2 week follow up |
|
|
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| Primary | 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. | For the VR-GI group, 3 participants were analyzed as others did not have opioid usage. For the AO-GI group, 4 participants were analyzed as others did not have opioid usage. | Posted | Number | Count of Participants with Reduced Opioi | Baseline to 2 week follow up |
|
|
|
| Primary | 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 | Posted | Number | Pt. count reduced non-opoid pain med use | Baseline to 2 week follow up |
|
|
|
| Secondary | 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. | For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires. | Posted | Mean | Standard Deviation | score on GAD-2 scale | Baseline to 2 week follow up |
|
|
|
| Secondary | 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. | For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires. | Posted | Mean | Standard Deviation | score on PHQ-2 scale | Baseline to 2 week follow up |
|
|
|
| Secondary | 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. | For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires. | Posted | Mean | Standard Deviation | score on SF 12 scale | Baseline to 2 week follow up |
|
|
|
| Secondary | 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. | For the VR-GI group, 9 participants out of the 12 participants with a CBP diagnosis were analyzed as 1 participant did not receive intervention, 1 participant discontinued intervention, and 1 did not complete a post-intervention questionnaire. For the AO-GI group, 6 participants were analyzed as they had a CBP diagnosis. | Posted | Mean | Standard Deviation | score on Oswestry Disability scale | Baseline to 2 week follow up |
|
|
|
| Secondary | 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. | CSS-17 was unreported due to participants receiving an incomplete CSS-17 questionnaire. | Posted | Baseline to 2 week follow up |
|
|
| Secondary | Daily Pain Numerical Rating Scale | Rating of current pain intensity from 0-10 with higher number indicated worse pain outcomes | For the VR-GI group, 23 participants were analyzed as one participant did not receive allocated intervention. For the AO-GI group, 11 participants were analyzed as one participant did not complete post-intervention questionnaires. | Posted | Mean | Standard Deviation | difference score on pain scale | Baseline to 2 week follow up |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 5 |
| 23 |
| EG001 | Audio Only Guided Imagery (AO-GI) | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Lowest Score Follow up |
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| Change in Highest Score Follow-up-Baseline |
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| Highest Score Baseline |
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| Highest Score Follow-up |
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| Change in Average Score Follow-up-baseline |
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| Average Score Baseline |
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| Average Score Follow-up |
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| GAD Follow-up |
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| PHQ Follow-up |
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| Physical Score Follow up |
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| Change in Mental Score (Follow-up - Baseline) |
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| Mental Score Baseline |
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| Mental Score Follow up |
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| ODI Follow up |
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| Post pain Score |
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