Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine80 enrolled

Overview

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.

Chronic secondary musculoskeletal pain is commonly associated with persistent pain and interference with daily activities, sleep, mood, and quality of life. This two-center, prospective, randomized, parallel-group, sham-controlled clinical trial evaluated PK-MPT, a mixed reality-based chronic pain rehabilitation software, in adults with chronic secondary musculoskeletal pain. Eligible participants were randomly assigned in a 1:1 ratio to the active PK-MPT intervention or PK-MPT Sham MR control. Both interventions were delivered using Microsoft HoloLens 2. Participants completed one 20-minute treatment session daily for 3 consecutive days. The active intervention presented a three-dimensional therapeutic environment, whereas the sham control presented a two-dimensional video through the same headset. The study assessed pain intensity using the Visual Analogue Scale and also evaluated participant-reported global improvement, pain catastrophizing, pain-related interference with activity, sleep, stress, and mood, system usability, treatment satisfaction, dizziness, adverse events, and device deficiencies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

Mixed Reality based analgesic therapyDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females ≥18 years old. * Average pain intensity≥4 on a 0-10 numerical rating scale (NRS) in the past 24 hours. * Be able to communicate in Chinese. * Be able to read and write Chinese. * Willing to comply with study procedures and restrictions. * Willing and able to sign informed consent. Exclusion Criteria: * Shingles on the eyes, ears, head, face, or hands. * Trigeminal neuralgia. * Severe vision impairment. (Patients with clear vision wearing glasses or contact lenses are allowed) * Severe hearing impairment. * Disease or medical condition predisposing to nausea or dizziness, such as insufficient blood supply to the brain, vestibular dysfunction,cholecystitis, etc. * History of severe motion sickness. * Injury to eyes, ears, face, or neck that impedes comfortable use of mixed reality. * Injury or dysfunction of hands or upper limbs that impedes comfortable use of mixed reality. * Diagnosis of cognitive impairment, epilepsy, dementia, migraines or other neurological diseases that may prevent the use of mixed reality. * History of mental illness, including depression, generalized anxiety disorder, schizophrenia, etc. * Females currently pregnant. * Current or completion of participation within 4 weeks before screening in any interventional clinical study * Patients whom the investigator considers not suitable to participate in this study.

Outcomes

Primary Outcomes

Change in pain intensity before and after MR therapy

The Pain intensity is measured using a 0-10 numerical rating scale (NRS) of pain. The scale is described to participants as: "Ten is the worst pain anyone could ever have, and zero is no pain at all." Before the MR therapy session begins, each participant is asked to rate their current pain level on the 0-10 numerical rating scale. After the 15-minute MR therapy session, the participant is immediately asked to rate their pain level again using the same 0-10 scale. The change in pain intensity is calculated as the difference between the pre-therapy and post-therapy pain level scores. (Time Frame: Baseline (pre-therapy) and immediately post-therapy (total assessment period: 20 minutes))

Time frame: 20minutes