Mixed Reality-Based Rehabilitation Software for 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.

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.