Virtual Reality for the Treatment of Chronic Low Back Pain

Back Pain Lower Back Chronic Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04273919
• Other study ID #: 834277
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

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
• HTC Vive with Lumen Program
HTC Vive head-mounted display with Lumen program

Locations

Country	Name	City	State
United States	Penn Pain Medicine Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact on opioid use	Impact on opioid use in patients on chronic opioids will be assessed by documentation of daily opioid dose in oral morphine equivalents.	12 weeks
Primary	Physical Functioning measured by PROMIS 6 (Patient Reported Outcome Measurement Information System)	Physical functioning reported on a scale 1 (unable to do) to 5 (without any difficulty)	12 weeks
Secondary	Patient-Reported Pain Intensity	Pain reported on a scale 0 (no pain) to 10 (worst pain possible)	12 weeks
Secondary	Disability measured by the Oswestry Low Back Disability Questionnaire	Disability reported on a scale 0 (can complete task) to 5 (can't complete tasks)	12 weeks
Secondary	Mental Functioning measured by PHQ-9 (Patient Health Questionnaire)	Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)	12 weeks
Secondary	Mental Functioning measured by GAD-7 (Generalized Anxiety Disorder)	Mental functioning reported on a scale 0 (not at all) to 3 (nearly every day)	12 weeks
Secondary	Adverse Events	Any symptom, sign, illness or experience that develops or worsens in severity during the course of the study will be documented	12 weeks

External Links

•   Karuna Labs FDA Establishment Registration