Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06936059

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua hospital ,Shanghai Jiaotong University, School of medicine

Shanghai, Shanghai Municipality, 20000, China

Location status: Recruiting

Location contact

Ke MA, Ph D

CONTACT

[email protected]

86-21-25078707 ext. 86-13361879260

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixed Reality based analgesic therapy

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.

Primary outcomes

  1. Change in pain intensity before and after MR therapy

    Time frame: 20min

    The pain intensity is measured using a 0-10 numerical rating scale (NRS) of pain. The anchors for the numerical rating scale were "Ten is the worst pain anyone could ever have and zero is no pain at all." Before the MR therapy started, the participant would be asked what his or her pain level is on the 0-10 numerical rating scale. After the 15 minute MR therapy, the participant would be asked what his or her pain level at that moment, again using the 0-10 numerical rating scale. The change in pain intensity before and after MR therapy is then obtained with the two pain level numbers subtracted.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.