Chronic PainNCT06936059
Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain
A study testing Mixed Reality based analgesic therapy in people with Chronic Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Mixed Reality based analgesic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2024to 26 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua hospital ,Shanghai Jiaotong University, School of medicine
Shanghai, Shanghai Municipality, 20000
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Mixed Reality based analgesic therapy
- Keywords
- pain, Visual Pain Score, rehab training software, anxious, depressed
- Medical subject headings
- Chronic Pain, Pain, Anxiety Disorders, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MR Therapy Group | Experimental | 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) Receives: Device: Mixed Reality based analgesic therapy |
| Non-MR Group | Placebo comparator | 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 Receives: Device: Mixed Reality based analgesic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start3 Jul 2024
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936059
- Sponsor's protocol ID
- XH-24-010
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the personal information privacy of participants
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06936059
- Acronym / sponsor ID
- XH-24-010
- Conditions
- Chronic Pain
- Keywords
- pain, Visual Pain Score, rehab training software, anxious, depressed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MR Therapy Group | Experimental | Device: Mixed Reality based analgesic therapy1. 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) |
| Non-MR Group | Placebo comparator | Device: Mixed Reality based analgesic therapy1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mixed Reality based analgesic therapyThe 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. | Device | MR Therapy Group, Non-MR Group |
Primary outcome
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))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. To protect the personal information privacy of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality based analgesic therapy in people with Chronic Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity before and after MR therapy (time frame: 20minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.