Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

August 16, 2026 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 20000
        • Xinhua hospital ,Shanghai Jiaotong University, School of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR Therapy Group
  1. Device: Mixed Reality based analgesic therapy
  2. Single 15-minute MR session using Pico Neo 3 Pro headset

  3. Content includes:

    • 7-minute computer-generated 360° underwater scene with therapeutic music (passive relaxation)
    • 8-minute guided relaxation at seaside with narrative (imagery and breathing relaxation)
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.
Placebo Comparator: Non-MR Group
  1. Device: Non-MR version of the same software
  2. Single 15-minute session using the same visual and audio content
  3. Presented on a standard display (not in mixed reality)
  4. Identical scenario but without immersive MR experience
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain intensity before and after MR therapy
Time Frame: 20minutes

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))
20minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

November 26, 2024

Study Completion (Actual)

November 26, 2024

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

April 13, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-24-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the personal information privacy of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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