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COMPLETED
NCT06936059
NA

Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

This study evaluated the efficacy and safety of a mixed reality-based chronic pain rehabilitation software (PK-MPT) for adults with chronic secondary musculoskeletal pain. Participants were randomly assigned to receive either the active PK-MPT intervention or a sham control delivered using the same mixed reality headset. Both groups completed one 20-minute session per day for 3 consecutive days. Pain intensity and other pain-related outcomes, as well as usability and safety, were assessed during treatment and follow-up.

Official title: A Prospective, Randomized, Parallel-Controlled Clinical Trial Evaluating the Efficacy and Safety of Chronic Pain Rehabilitation Software for the Adjunctive Relief of Chronic Secondary Musculoskeletal Pain

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-07-03

Completion Date

2024-11-26

Last Updated

2026-08-19

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Mixed Reality based analgesic therapy

The intervention is a single 15 minutes 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 7minutes of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8minutes 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.

Locations (1)

Xinhua hospital ,Shanghai Jiaotong University, School of medicine

Shanghai, Shanghai Municipality, China