Virtual Reality Therapy for Chronic Low Back Pain

Study Overview
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Brief Summary
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This study will test the effectiveness of an evidence-based virtual reality therapy program as a non-pharmacological supplement to managing patients with pain due to chronic lower back pain. Outpatients will be randomized to receive one of three virtual reality (VR) programs: skills-based VR, distraction VR, or sham VR. All patients will receive a VR headset and Fitbit Charge 4 watch. Study devices will be delivered to the patient's home with instructions for use via FedEx; patients will receive remote technical support. Patients will be followed for 90 days and monitored for functional status, pain levels, use of pain medications (including opioids). Participants will also be asked to consent/authorization to access medical records from their treating facility.

Detailed Description
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This is a randomized double-blind, placebo-controlled trial for individuals with chronic lower back pain. This study investigates the effect of at-home virtual reality (VR) pain reduction therapy on a set of outcome measures. The primary outcome is Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference version 8. This study will enroll 360 participants into one of three VR therapy groups. Data collection will occur at home via personal computer or smartphone (iphone/android), with baseline data collected one week before the intervention is mailed to the patient. The patient will have the VR headset for 90 days. A post-study survey will be sent to patients 30 days after the end of the study. To learn more about the study and to assess your eligibility, please visit our study website at https://virtualmedicine.org/research/current/vr4backpain

Official Title
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Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity

Conditions
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Chronic Lower Back Pain

Intervention / Treatment
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* Device: PICO G2 4k


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, above the age of 13. A back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months. English speaking. The participant has either a personal computer or a smartphone (android/iphone) to the web-based complete surveys. Exclusion Criteria: Are presenting with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions). Are being recommended for long-term hospitalization that would require more than three-week stay inside the hospital. Received recent surgery within the previous 8 weeks. Any planned surgeries in the next 3 months. Are currently using a spinal cord stimulator. Have lower back pain attributable to a recognizable, specific pathology, such as infection, tumor, fracture, or inflammatory spondylopathy. Previously participated in a virtual reality clinical trial.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Program A<br>This arm will include software that provides immersive skills-based content for pain reduction. | Device: PICO G2 4k<br>* Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.<br>|
| Active Comparator: Virtual Reality Program B<br>This arm will include software that provides immersive distraction based content for pain reduction. | Device: PICO G2 4k<br>* Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.<br>|
| Sham Comparator: Virtual Reality Program C<br>This arm will include software that provides nonimmersive distraction based content for pain reduction. | Device: PICO G2 4k<br>* Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System Pain Interference | The primary outcome for this study will be self-reported pain interference using Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) version 8. The pain interference scale measures the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is the 8 question version. The max score is 40 and the minimum is 8. The higher the score the worse the outcome. | This will be measured weekly for the first 4 weeks. The primary efficacy endpoint is the change from study baseline (Screening week, aka week -1) to week 4 in pain interference as measured by PROMIS-PI. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes Measurement Information System Pain Interference 8 | PROMIS Pain Interference 8 will also be assessed after the first month of the study at a biweekly interval. As stated above the pain interference scale measures the consequences of pain on relevant aspects of one's life. The max score is 40 and the minimum is 8. The higher the score the worse the outcome. | biweekly from week 6 to week 12 | 
| Pain Catastrophizing Survey Short Form 6 | Pain catastrophizing is a negative mental set regarding actual or anticipated pain, and includes aspects of rumination, magnification, and sense of helplessness. It will be measured using the Pain Catastrophizing scale (PCS) short form, which a 6-item questionnaire. The max score is 24 and the minimum is 0. The higher the score the worse the outcome. | biweekly until week 12 | 
| Patient-Reported Outcomes Measurement Information System Anxiety 4 | Anxiety is a commonly comorbid disease with chronic lower back pain. The PROMIS Anxiety scale will be used to assess it. This is the 4 question version of the scale. The max score is 20 and the minimum is 4. The higher the score the worse the outcome. | biweekly until week 12 | 
| Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a | Given the impact of chronic pain on mental health there is also an impact on sleep. PROMIS Sleep Disturbance is a well-validated survey to assess sleep quality. This is version A of the 6 item scale. The max score is 30 and the minimum is 6. The higher the score the worse the outcome. | biweekly until week 12 | 
| Use of Opioids | In order to capture use of opioids, we will link patient electronic health record (EHR) data to the other data sources using Medical Record Numbers and date of birth. We will also request access to the CURES database for research purposes. We will convert all opioid doses into a single metric using morphine milligram equivalents (MME). | The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Chronic Lower Back Pain, analgesia