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Study on the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Comorbid Rheumatoid Arthritis
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Summary
This multicenter, randomized, double-blind, sham-controlled trial aimed to evaluate the preventive efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) against central-sensitization-related pain in high-risk rheumatoid arthritis (RA) patients. A total of 124 eligible participants were randomized 1:1 to receive 4-week home-based real or sham taVNS. The primary outcome was the change in Central Sensitization Inventory-9 (CSI-9) score from baseline to week 4. Peripheral blood, faecal samples and brain MRI were collected to explore potential brain-gut-microbiome-related mechanisms. Our findings will provide high-quality evidence for this non-pharmacological intervention for RA-related central sensitization pain.
Official title: Evaluation of the Effectiveness and Mechanism of Traditional Chinese Medicine in Preventing Central Sensitization Pain in Rheumatoid Arthritis Based on Real-World Cohorts - Study on the Effect and Mechanism of Transcutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain Associated With Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2026-10-01
Completion Date
2029-10-01
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
taVNS
Treatment using the Huatuo electronic acupuncture device (model SDZ-IIB) with electrodes placed on the auricular points related to the heart and kidney. Pulsed wave type is sparse-dense wave, with a frequency of 20Hz and intensity set to the highest level tolerable without pain. Patients will perform self-treatment at home for 30 minutes, twice daily, for 5 days a week over 4 weeks.
Sham Stimulation
Treatment using the same Huatuo electronic acupuncture device with electrodes placed on different ear points (over the ear helix). The device settings (pulse type, frequency, intensity) are the same as the experimental group but do not correspond to traditional acupuncture points. Patients will also perform self-treatment at home as per the same schedule as the experimental group.