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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
Study Summary
This trial will test if virtual reality can help chronic lower back pain when used as a supplement to other treatments.
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.Check my eligibility
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.See study design
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient-Reported Outcomes Measurement Information System Pain Interference
Secondary outcome measures
Pain Catastrophizing Survey Short Form 6
Patient-Reported Outcomes Measurement Information System Anxiety 4
Patient-Reported Outcomes Measurement Information System Pain Interference 8
+2 moreOther outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,472 Total Patients Enrolled
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
483 Previous Clinical Trials
1,086,555 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had ongoing back pain for at least 3 months, and it has caused you pain on at least half of the days in the past 6 months.You have taken part in a study involving virtual reality before.You are older than 13 years old.Your lower back pain is caused by a specific problem like infection, tumor, fracture, or inflammation in the spine.You have a medical condition or injury that makes it unsafe for you to use virtual reality technology. This could include a history of seizures, facial injuries, vision problems, or significant hearing impairment.You are being recommended for a hospital stay that would last more than three weeks.You are currently using a device called a spinal cord stimulator.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality Program A
- Group 2: Virtual Reality Program B
- Group 3: Virtual Reality Program C
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are currently participating in this scientific investigation?
"Affirmative. Clinicaltrials.gov documents this trial, which was inaugurated on September 21st 2020, is presently hunting for participants. The study requires 360 volunteers from one medical centre to participate."
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