Virtual reality therapy for managing chronic low back pain
Extended Reality-Assisted Therapy for Chronic Pain Management: Can Immersive Virtual Reality Improve Range of Motion and Disability in Patients With Chronic Low Back Pain?
This study is testing if a virtual reality program can help people with chronic low back pain feel better and move more easily compared to just watching videos.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institut d'Investigacions Biomèdiques August Pi i Sunyer Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06296433 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a home-based virtual reality rehabilitation application for patients suffering from chronic low back pain. Participants will be randomly assigned to either a VR treatment group, where they will engage with a prototype VR application featuring educational content, gamified exercises, and relaxation techniques, or a control group that will watch 2D videos. The intervention will last for 20 minutes daily over a period of three weeks, and researchers will assess improvements in pain, daily function, range of motion, and fear of movement using validated outcome measures. The study seeks to determine if the VR application can provide better outcomes compared to passive VR experiences.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with a diagnosis of chronic low back pain lasting more than 12 weeks.
Not a fit: Patients with specific spinal conditions, recent surgeries, or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve daily functioning for patients with chronic low back pain.
How similar studies have performed: Other studies have shown promise in using virtual reality for pain management, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-65 of either sex * Diagnosis of chronic low back pain of \>12 weeks, with or without associated somatic referred leg pain * Average pain intensity over the previous month ≤7/10 and ≥ 2/10) Exclusion Criteria: * Spondylolysis, fracture, cauda equina syndrome, active spinal infection * Acute radiculopathy or compromised nerve root * Recent spinal surgery (\<12 months) or lower limb surgery (\<3 months) * Major depressive symptoms as indicated by the Patient Health Questionnaire-2 depression screen score of 4 or more. * Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, balance disorder, or other neurological diseases that may prevent the use of virtual reality or adverse effects. * Cardiopulmonary or pulmonary disorder with contraindication to physical exercise * Pregnancy
Where this trial is running
Barcelona
- Idibaps — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Maria V Sanchez-Vives — Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study coordinator: Tony Donegan
- Email: tonydonegan@gmail.com
- Phone: +34676606825
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.