A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain
NCT06936059 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2025-04-20
Summary
A prospective, randomized, parallel-controlled clinical trial to evaluate the effectiveness and safety of chronic pain rehabilitation training software in assisting in the relief of chronic secondary musculoskeletal pain
Conditions
Interventions
- DEVICE
-
Mixed Reality based analgesic therapy
The intervention is a single 15 min MR therapy. The MR therapy is consisted of MR device and software. The model of MR device used is Pico Neo 3 Pro. The software run on the MR device delivers two types of contents: 1) A 7min of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8min guided relaxation in which patients are transported to seaside with narrative to achieve image and breathing relaxation. And the placebo-group used the same non-mixed reality(Non-MR) scenario to treat patients, although the scenario is completely identical, it is not presented in a mixed reality scenario. It only presents the scene in normal display mode.
Sponsors & Collaborators
-
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-12
- Primary Completion
- 2026-11-12
- Completion
- 2026-11-12
Countries
- China
Study Locations
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