Evaluating the Safety and Effectiveness of Chronic Pain Rehabilitation Training Software Using Mixed Reality Therapy for Chronic Secondary Musculoskeletal Pain

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a chronic pain rehabilitation training software designed to assist in relieving chronic secondary musculoskeletal pain. This prospective, randomized, parallel-controlled clinical trial aims to compare outcomes using mixed reality MR based therapy against a non-mixed reality placebo version. The trial is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and focuses on adults experiencing chronic pain with significant intensity. The intervention involves a single 15-minute mixed reality therapy session using the Pico Neo 3 Pro device. This therapy includes a 7-minute computer-generated underwater scene with therapeutic music to distract and relax patients, followed by an 8-minute guided relaxation transporting patients to a seaside environment with narrative and breathing exercises. The placebo group receives the same visual content but displayed without mixed reality features, using a normal screen display. Participants will undergo assessments of pain intensity before and after the MR therapy lasting approximately 20 minutes. Researchers will measure changes in pain levels using a visual analog scale VAS. The study includes monitoring for safety and effectiveness of the therapy with no masking or blinding, and participants are expected to comply with all study procedures and restrictions throughout their involvement. The study begins in November 2025 and ends in November 2026.

A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain