- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04273919
Virtual Reality for the Treatment of Chronic Low Back Pain (VR)
A Pilot Study to Evaluate the Safety and Efficacy of the Karuna Virtual Reality Program for the Treatment of Chronic Low Back Pain
Chronic low back pain is highly prevalent in US adults and is a major cause of missed work days and disability. While several treatment options exist, chronic opioids are commonly used for these conditions even though there are limited data supporting efficacy, and clear evidence of harm associated with chronic opioid administration.
Virtual reality has been proposed as a treatment option that may lead to decreased pain and improved physical functioning, while avoiding the harms associated with medication management. This study is intended to obtain preliminary safety and efficacy data to guide the design of a larger clinical trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a pilot study to evaluate the safety and efficacy of the Kauruna Virtual Reality program for the treatment of chronic low back pain. This study is intended to document the safety and efficacy of the use of virtual reality for the treatment of chronic low back pain. The primary outcome measure will be physical functioning as measured by the PROMIS 6. Secondary outcome measures include patient-reported pain intensity, adverse side effects, disability as measured by the Oswestry Low back disability questionnaire, and mental functioning as assessed using the PHQ-9 and GAD-7. Finally, impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.
Forty adult patients with chronic low back pain who are receiving care through the Penn Pain Medicine Center are eligible to participate in the study. The study will consist of a screening visit, followed by randomization into 1 of 2 study groups. Both study groups will participate in two 20-minute virtual reality sessions a week for 8 weeks. Study group 1 will participate in 20 minutes of mindfulness mediation. Study Group 2 will undergo initial sessions focused on graded motor imagery, followed by sessions focused on graded exposure. Patient-reported outcomes data will be obtained at baseline, then weekly during the 8-week study period, then 4 weeks following completion of the study sessions.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Penn Pain Medicine Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age over 18
- Able to speak and read English
- A history of chronic low back pain for at least 6 months
- No changes to medications within 30 days of randomization
- Able to provide outcomes data through the electronic patient-reported outcome data collection system
Exclusion Criteria:
- Age less than 18 years.
- Pregnant women
- Cognitive impairment that limits ability to participate in the study, including the provision of outcome data through the electronic patient-reported outcome data collection system.
- Unable to stand for at least 15 minutes
- Employees or students of the University of Pennsylvania
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Mindfulness Mediation
Subjects will undergo virtual reality in a non-embodied (no first person bodily experience) program called Lumen, which was developed by Stanford University's Virtual Human Interaction Lab.
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HTC Vive head-mounted display with Lumen program
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Experimental: Graded Motor Imagery
The subjects will engage in 2 therapeutic modules intended to help them practice increasing range of motion safely, and using small movements of the lower back.
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HTC Vive head-mounted display and an HTC Vive body tracker adhered to a belt on the patient's low back, which will be placed 2 inches below the waist
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Functioning measured by PROMIS 6 (Patient Reported Outcome Measurement Information System)
Time Frame: 12 weeks
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Physical functioning reported on a scale 1 (unable to do) to 5 (without any difficulty)
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Pain Intensity
Time Frame: 12 weeks
|
Pain reported on a scale 0 (no pain) to 10 (worst pain possible)
|
12 weeks
|
Disability measured by the Oswestry Low Back Disability Questionnaire
Time Frame: 12 weeks
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Disability reported on a scale 0 (can complete task) to 5 (can't complete tasks)
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12 weeks
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Mental Functioning measured by PHQ-9 (Patient Health Questionnaire)
Time Frame: 12 weeks
|
Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)
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12 weeks
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Mental Functioning measured by GAD-7 (Generalized Anxiety Disorder)
Time Frame: 12 weeks
|
Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)
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12 weeks
|
Adverse Events
Time Frame: 12 weeks
|
Any symptom, sign, illness or experience that develops or worsens in severity during the course of the study will be documented
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact on opioid use
Time Frame: 12 weeks
|
Impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael A Ashburn, MD, MPH, Physician
Publications and helpful links
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
- 834277
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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