NCT06296433 Extended Reality-Assisted Therapy for Chronic Pain Management

Trial Parameters

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Brief Summary

The goal of this clinical trial is to test a home-based virtual reality rehabilitation application in patients with chronic low back pain. The main question it aims to answer are: Is a prototype of a novel VR software application effective at reducing pain, improving daily function, improving range of motion, and reducing fear of movement in adult patients with chronic low back pain compared with a passive VR intervention? Participants in the treatment group will use the application daily for 20 minutes for a period of 3 weeks at home and unsupervised. Researchers will compare use of the VR application with a control group that watches 2D video to see if the treatment group have improved pain, disability, range of motion, and fear of movement.

Eligibility 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

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