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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
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-04-20
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a chronic pain rehabilitation training software designed to assist in relieving chronic secondary musculoskeletal pain. This prospective, randomized, parallel-controlled clinical trial aims to compare outcomes using mixed reality (MR) based therapy against a non-mixed reality placebo version. The trial is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and focuses on adults experiencing chronic pain with significant intensity. The intervention involves a single 15-minute mixed reality therapy session using the Pico Neo 3 Pro device. This therapy includes a 7-minute computer-generated underwater scene with therapeutic music to distract and relax patients, followed by an 8-minute guided relaxation transporting patients to a seaside environment with narrative and breathing exercises. The placebo group receives the same visual content but displayed without mixed reality features, using a normal screen display. Participants will undergo assessments of pain intensity before and after the MR therapy lasting approximately 20 minutes. Researchers will measure changes in pain levels using a visual analog scale (VAS). The study includes monitoring for safety and effectiveness of the therapy with no masking or blinding, and participants are expected to comply with all study procedures and restrictions throughout their involvement. The study begins in November 2025 and ends in November 2026.
CONDITIONS
Brief Title
A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females 18 years old or older
- Average pain intensity of 4 or higher on a 0-10 numerical rating scale in the past 24 hours
- Ability to communicate in Chinese
- Ability to read and write Chinese
- Willingness to comply with study procedures and restrictions
- Willing and able to sign informed consent
You will not qualify if you...
- Shingles affecting eyes, ears, head, face, or hands
- Trigeminal neuralgia
- Severe vision impairment not corrected by glasses or contacts
- Severe hearing impairment
- Medical conditions that cause nausea or dizziness, such as poor brain blood supply, vestibular problems, or cholecystitis
- History of severe motion sickness
- Injuries to eyes, ears, face, or neck that prevent comfortable use of mixed reality
- Injuries or dysfunction of hands or upper limbs that prevent comfortable use of mixed reality
- Diagnosis of cognitive impairment, epilepsy, dementia, migraines, or other neurological disorders that may impede use of mixed reality
- History of mental illness including depression, generalized anxiety disorder, or schizophrenia
- Females who are currently pregnant
- Participation in any interventional clinical study within 4 weeks before screening
- Any condition the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session
Participants receive a single 15-minute session of mixed reality based analgesic therapy or a placebo non-mixed reality scenario to help relieve chronic secondary musculoskeletal pain.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Xinhua hospital ,Shanghai Jiaotong University, School of medicine
Shanghai, Shanghai Municipality, China, 20000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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