What side effects are associated with this type of intervention?

Common treatments for chronic lower back pain include virtual reality (VR) therapy, acupuncture, and spinal cord stimulation. VR therapy is generally well-tolerated, but some users may experience mild side effects such as dizziness, nausea, or eye strain. Acupuncture is considered safe with minimal side effects, though some patients may experience minor bruising or soreness at needle sites. Spinal cord stimulation can be effective but carries risks such as infection, lead migration, and hardware complications. Overall, these treatments offer non-pharmacological options with relatively low risk profiles for managing chronic lower back pain.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic lower back pain, including spinal cord stimulation (SCS), which involves electrical impulses to modulate pain signals. SCS has been shown to be effective in reducing pain and improving function in patients with chronic pain conditions, including those with failed back surgery syndrome. While virtual reality therapy for chronic lower back pain is still under investigation, it represents a promising non-pharmacologic approach similar to SCS in its goal of modulating pain perception through cognitive and sensory engagement.

What other types of research exist?

Promising, novel alternatives to Virtual Reality Therapy for chronic lower back pain include: 1) Guided Imagery and Progressive Muscle Relaxation, which have been shown to reduce pain and improve health-related outcomes in various patient populations. 2) Cognitive Behavioral Therapy (CBT), which has been effective in managing chronic pain through psychological and behavioral strategies. 3) Neurofeedback, which has demonstrated long-term impact on symptom burden and pain interference. 4) Surface Electromyography (EMG)-assisted stretching, which aids in chronic musculoskeletal pain rehabilitation.

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Virtual Reality Therapy for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Brennan Spiegel, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the average for 30 days before day 1 and the 30 day average at 90 day will be compared within the study.

Awards & highlights

Summary

This trial tests virtual reality (VR) therapy to help people with chronic lower back pain. Participants will use VR headsets at home for a few months, with programs designed to teach pain management or distract from pain. The study aims to see if these VR programs can reduce pain and improve daily function. Virtual reality (VR) has been shown to reduce pain in various settings, including surgical recovery and burn wound care.

Who is the study for?

This trial is for individuals over the age of 13 with chronic lower back pain lasting at least 3 months, experiencing pain on most days in the past 6 months. Participants must speak English and have a computer or smartphone to complete surveys. They should be willing to follow study procedures for 90 days but can't join if they've been in VR trials before, have certain health conditions like seizures or severe hearing loss, recent surgeries, planned surgeries within three months, use spinal cord stimulators, or specific pathologies causing their back pain.

What is being tested?

The study tests virtual reality therapy's effectiveness as an additional treatment for chronic low back pain. Patients will randomly receive one of three VR programs: skills-based VR, distraction VR, or sham (fake) VR using a PICO G2 4k headset and Fitbit Charge watch from home. Their functional status and medication usage will be monitored remotely over a period of three months.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort wearing the headset due to prolonged use; motion sickness known as 'VR sickness'; eye strain; headaches; and possibly disorientation after using the virtual reality system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the average for 30 days before day 1 and the 30 day average at 90 day will be compared within the study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the average for 30 days before day 1 and the 30 day average at 90 day will be compared within the study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the average for 30 days before day 1 and the 30 day average at 90 day will be compared within the study. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-Reported Outcomes Measurement Information System Pain Interference

Secondary study objectives

Pain Catastrophizing Survey Short Form 6

Patient-Reported Outcomes Measurement Information System Anxiety 4

Patient-Reported Outcomes Measurement Information System Pain Interference 8

+2 more

Other study objectives

Biometric data from Fitbit Charge 4 - Physical Activity

Biometric data from Fitbit Charge 4 - Sleep Quantity

Patient-Reported Outcomes Measurement Information System Depression 4

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Virtual Reality Program AExperimental Treatment1 Intervention

This arm will include software that provides immersive skills-based content for pain reduction.

Group II: Virtual Reality Program BActive Control1 Intervention

This arm will include software that provides immersive distraction based content for pain reduction.

Group III: Virtual Reality Program CPlacebo Group1 Intervention

This arm will include software that provides nonimmersive distraction based content for pain reduction.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PICO G2 4k

2020

N/A

~390

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Lower Back Pain (CLBP) that modulate pain perception through cognitive and sensory engagement include cognitive-behavioral therapy (CBT), pain neuroscience education, and Virtual Reality (VR) therapy. These treatments work by altering the brain's interpretation of pain signals, thereby reducing pain intensity and improving functional outcomes. CBT focuses on changing negative thought patterns and behaviors associated with pain, while pain neuroscience education aims to increase understanding of pain mechanisms, reducing fear and anxiety. VR therapy immerses patients in interactive environments that distract and engage the brain, effectively reducing pain perception. These approaches are crucial for CLBP patients as they address both the physical and psychological components of pain, offering a comprehensive treatment strategy.

Virtual reality exergame for supplementing multimodal pain therapy in older adults with chronic back pain: a randomized controlled pilot study.Virtual Reality Analgesia With Interactive Eye Tracking During Brief Thermal Pain Stimuli: A Randomized Controlled Trial (Crossover Design).Self-Administered Behavioral Skills-Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

509 Previous Clinical Trials

165,528 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

493 Previous Clinical Trials

1,089,045 Total Patients Enrolled

Brennan Spiegel, MDPrincipal Investigator - Cedars-Sinai

Cedars-Sinai Medical Center, Ronald Reagan UCLA Medical Center

New York Medical College (Medical School)

Ucla School Of Medicine (Residency)

Media Library

PICO G2 4k Clinical Trial Eligibility Overview. Trial Name: NCT04409353 — N/A

Chronic Lower Back Pain Research Study Groups: Virtual Reality Program A, Virtual Reality Program B, Virtual Reality Program C

Chronic Lower Back Pain Clinical Trial 2023: PICO G2 4k Highlights & Side Effects. Trial Name: NCT04409353 — N/A

PICO G2 4k 2023 Treatment Timeline for Medical Study. Trial Name: NCT04409353 — N/A

~78 spots leftby Sep 2025

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