NCT04273919

Virtual Reality for the Treatment of Chronic Low Back Pain

A Pilot Study to Evaluate the Safety and Efficacy of the Karuna Virtual Reality Program for the Treatment of Chronic Low Back Pain

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Back Pain Lower Back Chronic

Interventions

Type	Name	Description
DEVICE	HTC Vive with Karuna Virtual Reality Program	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
DEVICE	HTC Vive with Lumen Program	HTC Vive head-mounted display with Lumen program

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-02-01
• Completion: 2022-02-01
• First posted: 2020-02-18
• Last updated: 2023-03-16

Locations

1 site across 1 country: United States