Virtual Reality for the Treatment of Chronic Low Back Pain

NCT ID: NCT04273919

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-02-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

HTC Vive with Lumen Program

Intervention Type: DEVICE

HTC Vive head-mounted display with Lumen program

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.

Group Type: EXPERIMENTAL

HTC Vive with Karuna Virtual Reality Program

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

HTC Vive with Lumen Program

HTC Vive head-mounted display with Lumen program

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Michael Ashburn, MD, MPH

Director of Pain Medicine and Palliative Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Ashburn, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

Penn Pain Medicine Center

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=211533

Karuna Labs FDA Establishment Registration

Other Identifiers

834277

Identifier Type: -

Identifier Source: org_study_id