Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

Chronic secondary musculoskeletal pain is commonly associated with persistent pain and interference with daily activities, sleep, mood, and quality of life. This two-center, prospective, randomized, parallel-group, sham-controlled clinical trial evaluated PK-MPT, a mixed reality-based chronic pain rehabilitation software, in adults with chronic secondary musculoskeletal pain.

Eligible participants were randomly assigned in a 1:1 ratio to the active PK-MPT intervention or PK-MPT Sham MR control. Both interventions were delivered using Microsoft HoloLens 2. Participants completed one 20-minute treatment session daily for 3 consecutive days. The active intervention presented a three-dimensional therapeutic environment, whereas the sham control presented a two-dimensional video through the same headset.

The study assessed pain intensity using the Visual Analogue Scale and also evaluated participant-reported global improvement, pain catastrophizing, pain-related interference with activity, sleep, stress, and mood, system usability, treatment satisfaction, dizziness, adverse events, and device deficiencies.

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.