- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409353
Virtual Reality Therapy for Chronic Low Back Pain
Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
Study Overview
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samuel Eberlein, MS
- Phone Number: 310-423-6721
- Email: samuel.eberlein@cshs.org
Study Contact Backup
- Name: Zoe Krut, MS
- Phone Number: 310-423-0699
- Email: zoe.krut@cshs.org
Study Locations
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California
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Los Angeles, California, United States, 90048
- Samuel Eberlein
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Virtual Reality Program A
This arm will include software that provides immersive skills-based content for pain reduction.
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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.
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Sham Comparator: Virtual Reality Program C
This arm will include software that provides nonimmersive distraction based content for pain reduction.
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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.
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Active Comparator: Virtual Reality Program B
This arm will include software that provides immersive distraction based content for pain reduction.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System Pain Interference
Time Frame: 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.
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System Pain Interference 8
Time Frame: biweekly from week 6 to week 12
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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.
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biweekly from week 6 to week 12
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Pain Catastrophizing Survey Short Form 6
Time Frame: biweekly until week 12
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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.
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biweekly until week 12
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Patient-Reported Outcomes Measurement Information System Anxiety 4
Time Frame: biweekly until week 12
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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.
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biweekly until week 12
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Patient-Reported Outcomes Measurement Information System Sleep Disturbance 6a
Time Frame: biweekly until week 12
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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.
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biweekly until week 12
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Use of Opioids
Time Frame: The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.
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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).
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The average for 30 days before Day 1 and the 30 day average at 90 day will be compared within the study.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Outcomes Measurement Information System Physical Function 6b
Time Frame: biweekly basis until week 12
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For patients with chronic pain, physical function is often diminished and patients seek return to normal function.
The Patient-Reported Outcomes Measurement Information System Physical Function short-form 6b scale is a widely- validated instrument with excellent content validity, construct validity, and reliability in patients with spinal disorders and other conditions marked by diminished mobility.
The instrument places patients on a continuum of function from extremely low to very high across activities that require physical actions, ranging from self-care to more complex activities that require a combination of skills.
The max score is 30 and the minimum is 6.
The higher the score the worse the outcome.
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biweekly basis until week 12
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Patient-Reported Outcomes Measurement Information System Depression 4
Time Frame: biweekly until week 12
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Depression is a commonly comorbid disease with chronic lower back pain.
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scale will be used to assess it.
This is the 4 item version of the scale.
The max score is 20 and the minimum is 4. The higher the score the worse the outcome.
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biweekly until week 12
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Biometric data from Fitbit Charge 4 - Physical Activity
Time Frame: Continuously from week 1 to week 12
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The total steps per day per day will be collected to assess physical activity.
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Continuously from week 1 to week 12
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Biometric data from Fitbit Charge 4 - Sleep Quantity
Time Frame: Continuously from week 1 to week 12
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The total hours of sleep per night as well as sleep efficiency will be assessed for the quantity of sleep using the Fitbit charge 4. Data will be analyzed using the Fitabase system.
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Continuously from week 1 to week 12
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brennan Spiegel, MD, Cedars-Sinai
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00000631
- 1UG3AR076573-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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