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Randomized, 2-arm parallel group clinical trial evaluating the effectiveness of a self-administered Virtual Reality program for the treatment of chronic lower back pain compared to a placebo VR program.
A randomized, 2-arm parallel-group clinical trial evaluating the effectiveness of a self-administered Virtual Reality (VR) program for the treatment of chronic lower back pain. The primary objective of this study is to assess the impact of skills-based VR on changes in patient-reported pain and pain interference over the course of an 8-week intervention as well as compared to a placebo VR condition. The secondary objective is to assess the impact of skill-based VR on changes in patient-reported satisfaction over the course of an 8-week intervention and compared to a placebo VR condition. A tertiary objective is to assess the impact of skills-based VR on changes in patient-reported opioid use, physical function, behavioral skills development, and health outcomes immediately following the intervention relative to a pre-intervention baseline and compared to a placebo VR condition. An exploratory objective is to assess the impact of skills-based VR on changes in patient-reported pain levels, opioid use, physical function, behavioral skills development, health outcomes, and satisfaction at the 24-week post-intervention time point and compared to a placebo VR condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Program A | Experimental | Software with active intervention |
|
| VR Program B | Active Comparator | Software without active intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EaseVRx headset with active intervention | Device | VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management. |
| Measure | Description | Time Frame |
|---|---|---|
| Department of Defense (DoD)/VA Pain scale | DoD/VA Pain scale measures pain intensity, and inference around activity, sleep, mood, and stress, each on an 11-point scale. The max score is 50 and the minimum is 0. The higher the score the worse the outcome. This will be assessed twice weekly during the 8-week intervention intervention period. | The primary efficacy endpoint is the change from study baseline to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Global Impression of Change Scale | Single item Patient's Global Impression of Change Scale (PGIC), self-reported the level of change (if any) in activity limitations, symptoms, emotions, and overall quality of life-related to your painful condition on a 7-point scale. The higher the number the better the outcome. | twice weekly during 8-week intervention, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Device utilization Questionnaire | Self-reported number of VR sessions completed since the participant last reported. The scale is 0-4 or more. The higher than number the higher the usage. | twice weekly during 8-week intervention, Day 56 |
| VR Satisfaction Scale |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Garcia, PhD | AppliedVR Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AppliedVR, Inc. | Los Angeles | California | 90067 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35612905 | Derived | Garcia L, Birckhead B, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Castro C, Maddox R, Maddox T, Darnall BD. Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. J Med Internet Res. 2022 May 25;24(5):e37480. doi: 10.2196/37480. | |
| 34902548 |
| Label | URL |
|---|---|
| webpage to assess if the study is right for you | View source |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| EaseVRx headset without active intervention | Device | VR software developed by AppliedVR with neutral non-interactive content. |
|
Satisfaction ratings regarding the ability of the VR program to relieve pain symptoms on a 5-point scale. One is defined as strongly disagree with the statement and five is defined as strongly agree. The higher the number the better the outcome. |
| Day 56 |
| Custom Opioid Use Survey | Custom survey assesses the use of opioids, frequency of use, dose of medication, happiness with regimen, and interest in change in treatment. | Baseline, Day 56 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | This 6-item PROMIS physical function measure assesses physical function such as (chores, running errands) on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the better the outcome. | Baseline, Day 56 |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance | 6-item PROMIS sleep disturbance measure assesses the level of sleep disturbance on a 5-point scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome. | Baseline, Day 56 |
| Pain Self-efficacy Questionnaire | 2-item PSEQ (PSEQ-2) assesses pain self-efficacy on a 7-point scale. The max score is 12 and the minimum is 0. The higher the score the better the outcome. | Baseline, Day 56 |
| Pain Catastrophizing Scale | 4 items from the Pain Catastrophizing Scale (PCS) assesses frequency of pain-related thoughts and feelings on a 5-point scale. The max score is 16 and the minimum is 0. The higher the score the worse the outcome. | Baseline, Day 56 |
| Chronic Pain Acceptance Questionnaire | 8-item Chronic Pain Acceptance (CPAQ-8) questionnaire assesses acceptance or psychological flexibility associated with chronic pain on a 7-point scale. The max score is 56 and the minimum is 8. The higher the score the better the outcome. | Baseline, Day 56 |
| Behavioral Skills Assessment | Custom survey assesses the development of skills to manage pain outside of the VR headset. This is only included in the EaseVRx condition. There are 4 knowledge questions. These are on a 1-5 scale from do not agree to completely agree. The skills questions are on a 0 to 10 scale with 0 being not at all confident and 10 being very confident. | Day 56 |
| Health Utilization Outcomes Questionnaire | Questionnaire on the frequency of steroid injections, lower back surgery, emergency department visits, hospital admissions, and unplanned physician visits over various time periods. The first part of each of these questions asks if they have had the service and then the second part asks for the frequency. | Day 56 |
| VR Use Data | VR use calculated as the total number of sessions launched. It will be continuous data stored on the headset. | Day 1 through Day 56 |
| Derived |
| Garcia LM, Birckhead BJ, Krishnamurthy P, Mackey I, Sackman J, Salmasi V, Louis R, Maddox T, Darnall BD. Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. J Pain. 2022 May;23(5):822-840. doi: 10.1016/j.jpain.2021.12.002. Epub 2021 Dec 11. |
| 33484240 | Derived | Garcia LM, Birckhead BJ, Krishnamurthy P, Sackman J, Mackey IG, Louis RG, Salmasi V, Maddox T, Darnall BD. An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19. J Med Internet Res. 2021 Feb 22;23(2):e26292. doi: 10.2196/26292. |
| 33464215 | Derived | Garcia LM, Darnall BD, Krishnamurthy P, Mackey IG, Sackman J, Louis RG, Maddox T, Birckhead BJ. Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 19;10(1):e25291. doi: 10.2196/25291. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |