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Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

CompletedNA

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Conditions: Chronic Pain

Interventions: Mixed Reality based analgesic therapy

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Shanghai, Shanghai Municipality, China