Virtual Reality for the Treatment of Chronic Low Back Pain

NCT04273919 | Withdrawn

• 1 other identifier: 834277
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient-Reported Pain Intensity

  12 weeks

• Disability measured by the Oswestry Low Back Disability Questionnaire

  12 weeks

• Mental Functioning measured by PHQ-9 (Patient Health Questionnaire)

  12 weeks

• Mental Functioning measured by GAD-7 (Generalized Anxiety Disorder)

  12 weeks

• Adverse Events

  12 weeks

Other Outcomes (1)

• Impact on opioid use

  12 weeks

Study Arms (2)

Mindfulness Mediation

SHAM COMPARATOR

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.

Device: HTC Vive with Lumen Program

Graded Motor Imagery

EXPERIMENTAL

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.

Device: HTC Vive with Karuna Virtual Reality Program

Interventions

HTC Vive with Karuna Virtual Reality Program 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

Graded Motor Imagery

HTC Vive with Lumen Program DEVICE

HTC Vive head-mounted display with Lumen program

Mindfulness Mediation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Pain Medicine Center

Philadelphia, Pennsylvania, 19146, United States

Location

Related Links

• Karuna Labs FDA Establishment Registration

Study Officials

• Michael A Ashburn, MD, MPH

  Physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pain Medicine and Palliative Care

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 18, 2020
• Study Start: August 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)