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the Effect and Mechanism of Percutaneous Auricular Electrical Stimulation in Preventing Central Sensitization Pain in Patients With Rheumatoid Arthritis

Study acronym: taVNS for Pain
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study title shortened, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07870564
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Sichuan Province Orthopetic Hospital, Inner Mongolia Hospital of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Shenzhen traditional Chinese medical hospital, Centre Hospitalier Universitaire de Saint Etienne
Conditions
(from sponsor)		 Rheumatoid Arthritis (RA), Transcutaneous Vagus Nerve Stimulation
Related terms Arthritis, Rheumatoid
Enrollment 124 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov