Evaluating a new therapy for chronic pain using mixed reality technology

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ke Ma
  Shanghai, Yangpu, China Recruiting

Study contacts

• Study coordinator: Ke NA Ma, phd
• Email: marke72@163.com
• Phone: 13361879260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.