Evaluating a new therapy for chronic pain using mixed reality technology

A Clinical Study on the Efficacy of Cognitive Distraction Focus Relaxation Therapy Based on MR in the Treatment of Chronic Pain: a Multicenter, Randomized Controlled, Single Blind Clinical Study

This study is testing a new mixed reality therapy to see if it can help people with chronic pain feel better and manage their discomfort.

Quick facts

• Study type: Observational
• Enrollment: 132 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Yangpu)
• Trial ID: NCT06290011 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness and safety of a cognitive distraction focus relaxation therapy based on mixed reality (MR) technology for patients suffering from chronic moderate to severe pain. It is a multi-center, prospective, single-blind, randomized, and parallel controlled trial designed to assess the analgesic effects of this innovative digital treatment system. Participants will be monitored for pain relief and any potential side effects associated with the therapy. The study aims to provide insights into how MR can enhance pain management strategies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have been clinically diagnosed with chronic pain lasting more than three months.

Not a fit: Patients with serious cognitive impairments or neurological conditions that may interfere with the use of mixed reality technology are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a novel, non-invasive approach to managing chronic pain, improving patients' quality of life.

How similar studies have performed: While the use of mixed reality in pain management is a relatively novel approach, preliminary studies have shown promising results in similar therapeutic applications.

Eligibility criteria

Inclusion Criteria:

1. 18-85 years old male and female;
2. Patients clinically diagnosed with chronic pain;
3. Chronic pain lasts for more than 3 months;
4. The average intensity of pain in the past month is 40mm and above (VAS);
5. Willing to abide by the relevant regulations of the experiment;

Exclusion Criteria:

1. Serious cognitive impairment;
2. Current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects;
3. Symptoms of nausea or dizziness;
4. Sensitive to luminous screens;
5. No stereo vision or severe hearing impairment;
6. Eye, face or neck injuries, which hinder the comfortable use of glasses;
7. The evaluated patient GAD-7 questionnaire 10 points and above, PHQ-9 questionnaire 10 points or above;
8. Have used VR or MR and other related devices to treat pain;
9. Other clinical studies have been completed now or recently (the past 2 months);
10. Currently pregnant or planning to get pregnant during the study;
11. At present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.

Where this trial is running

Shanghai, Yangpu

• Ke Ma — Shanghai, Yangpu, China (RECRUITING)

Study contacts

• Study coordinator: Ke NA Ma, phd

Conditions: Pain