Virtual Reality Therapy for Chronic Low Back Pain
CompletedNot applicableNCT04409353
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study will test the efficacy of an evidence-based virtual reality (VR) therapy program as a non-pharmacological supplement for the management of chronic lower back pain. Study participants will be randomized to receive one of three VR programs: Skills-Based VR, Distraction VR, or Sham VR. In addition to a VR headset, all participants will receive a Fitbit Charge 4 watch. Study devices will be delivered to the participant's home with instructions for use via FedEx; participants will receive remote technical support. They will be followed for 90 days and complete Patient Reported Outcome (PRO) questionnaires to assess functional status, pain levels, and use of pain medications (including opioids). Participants will also be asked to provide consent/authorization to access medical records from their treating facility.
Study details
- Official title
- Randomized-controlled Trial of Virtual Reality for Chronic Low Back Pain to Improve Patient-reported Outcomes and Physical Activity
- Conditions
- Interventions
- Device: Distraction-Based VR
- Device: Sham VR
- Device: Skills-Based VR
- Device: Activity Tracker
- Sponsor
- Cedars-Sinai Medical Center
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Start date
- 2020-09-21
- Primary completion
- 2023-10-17
- Sex
- All
- Age range
- from 13 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Able to provide consent to participate in research 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, age 13 or older 4. An ongoing low back-pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months. 5. Ability to comprehend spoken and written English 6. Owns a compatible android or iOS smartphone, or personal laptop or desktop computer (excluding tablets) to complete surveys and has access to email. Exclusion Criteria: 1. Presents with a condition that interferes with virtual reality usage, including history of seizure, facial injury precluding safe placement of headset, significant visual or hearing impairment that impacts ability to see the virtual reality images or follow audio instructions 2. Are being recommended for long-term hospitalization that would require more than three-week stay in the hospital 3. Received surgical procedure within the previous 8 weeks 4. Surgery is planned within the next 3 months 5. Is currently using a spinal cord stimulator 6. Has low back pain attributable to a recognizable, specific pathology, including spinal infection, cancer, fracture, or inflammatory spondylopathies, consistent with the NIH Task force on Research Standards for chronic low back pain 7. Previously participated in a virtual reality clinical trial
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04409353