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.
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Parallel
taVNS
DeviceTreatment 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
DeviceTreatment 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.
Change from baseline in Central Sensitization Inventory-9 (CSI-9) score at Week 4 of treatment.
The Central Sensitization Inventory-9 (CSI-9), a 9-item short-form self-report questionnaire derived from CSI-25, is used to assess symptoms of central sensitization in patients with chronic pain
Visual Analogue Scale (VAS) for pain
The Visual Analogue Scale (VAS) for pain is a widely-used self-reported unidimensional tool to quantify the subjective intensity of clinical pain.
Polysymptomatic Distress Scale (PDS)
The Polysymptomatic Distress Scale (PDS) evaluates widespread somatic symptom burden and is commonly applied for screening and assessing fibromyalgia-related symptomatology.
Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) is a validated questionnaire measuring pain severity and pain-related interference with daily function in patients with chronic pain conditions.
Fibromyalgia Impact Questionnaire-Revised (FIQR)
The Fibromyalgia Impact Questionnaire-Revised (FIQR) assesses overall disease impact including physical function, symptoms and quality of life among patients with fibromyalgia-like chronic pai
Semi-Quantitative Food Frequency Questionnaire (SFFQ)
The Semi-Quantitative Food Frequency Questionnaire (SFFQ) captures habitual dietary intake and food consumption frequency for nutritional and epidemiological research.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Lead sponsor
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Collaborator
Sichuan Province Orthopetic Hospital
Collaborator
Inner Mongolia Hospital of Traditional Chinese Medicine
Collaborator
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Collaborator
Shenzhen traditional Chinese medical hospital
Collaborator
Centre Hospitalier Universitaire de Saint Etienne
Collaborator
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