A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Chronic Pain

Treatments: Device: Mixed Reality based analgesic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06936059

XH-24-010

Details and patient eligibility

About

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

Full description

A PRPCT to assess the efficacy & safety of chronic pain rehab training software for alleviating chronic secondary musculoskeletal pain

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups, including a placebo group

Change in pain intensity before and after MR therapy

Experimental group

Description:

A 30% decrease in VAS score compared to the screening period is valid

Treatment:

Device: Mixed Reality based analgesic therapy

Placebo version of chronic pain rehabilitation training software

Placebo Comparator group

Description:

We use the same non-mixed reality（Non-MR） scenario to treat patients, although the scenario is completely identical, it is not presented in a mixed reality scenario.

Treatment:

Device: Mixed Reality based analgesic therapy