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the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis (taVNS for Pain)
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
- Sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Academic or other)
- Enrolment
- 124 planned
- Conditions
- Rheumatoid Arthritis (RA); Transcutaneous Vagus Nerve Stimulation
- Interventions
- taVNS; Sham Stimulation
- Ages
- adults, older adults
- Registry
- NCT07870564
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from baseline in Central Sensitization Inventory-9 (CSI-9) score at Week 4 of treatment.
History
Primary completion expected
Last registry update
Registered
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