A PRPCT to Assess the Efficacy & Safety of Chronic Pain Rehab Training Software for Alleviating Chronic Secondary Musculoskeletal Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mixed Reality based analgesic therapy.
- Who it may be relevant to
- Registry conditions: Chronic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Detailed description
A PRPCT to assess the efficacy \& safety of chronic pain rehab training software for alleviating chronic secondary musculoskeletal pain
Interventions
- Device Mixed Reality based analgesic therapy
The intervention is a single 15 min MR therapy. The MR therapy is consisted of MR device and software. The model of MR device used is Pico Neo 3 Pro. The software run on the MR device delivers two types of contents: 1) A 7min of computer-generated 360 video of underwater scene with therapeutic music to distract patients' attention on pain and make patients passively relax. 2) An 8min guided relaxation in which patients are transported to seaside with narrative to achieve image and breathing rela
Primary outcome measures
- Change in pain intensity before and after MR therapy [Time frame: 20min]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xinhua hospital ,Shanghai Jiaotong University, School of medicine — Shanghai
Identifiers
NCT: NCT06936059 · XH-24-010