A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain

NCT ID: NCT06936059

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-12
• Study Completion Date: 2026-11-12

Brief 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

Detailed Description

A PRPCT to assess the efficacy & safety of chronic pain rehab training software for alleviating chronic secondary musculoskeletal pain

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Change in pain intensity before and after MR therapy

A 30% decrease in VAS score compared to the screening period is valid

Group Type: EXPERIMENTAL

Mixed Reality based analgesic therapy

Intervention Type: DEVICE

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.

Placebo version of chronic pain rehabilitation training software

We use 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.

Group Type: PLACEBO_COMPARATOR

Mixed Reality based analgesic therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xinhua hospital ,Shanghai Jiaotong University, School of medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ke MA, Ph D

Role: primary

marke72@163.com

86-21-25078707 ext. 86-13361879260

Other Identifiers

XH-24-010

Identifier Type: -

Identifier Source: org_study_id