Using software to help relieve chronic 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
This study is testing a new software that uses mixed reality to see if it can help people with chronic musculoskeletal pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06936059 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a rehabilitation training software designed for chronic pain relief, specifically targeting secondary musculoskeletal pain. Participants will engage in mixed reality-based analgesic therapy, which aims to alleviate pain through innovative technology. The study is prospective, randomized, and parallel-controlled, ensuring a robust methodology to assess outcomes. Participants will be monitored for pain intensity and overall well-being throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience an average pain intensity of 4 or higher on a numerical rating scale and can communicate in Chinese.
Not a fit: Patients with severe vision or hearing impairments, cognitive impairments, or certain medical conditions that could interfere with the use of mixed reality technology may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve pain management for patients suffering from chronic musculoskeletal pain.
How similar studies have performed: While the use of technology in pain management is an emerging field, this specific approach using mixed reality for chronic pain rehabilitation is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Xinhua hospital ,Shanghai Jiaotong University, School of medicine — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.