Mixed Reality-Based Rehabilitation Software for Chronic Secondary Musculoskeletal Pain

A Prospective, Randomized, Parallel-Controlled Clinical Trial Evaluating the Efficacy and Safety of Chronic Pain Rehabilitation Software for the Adjunctive Relief of 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.

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.