Trials Sponsors Conditions Drugs Pricing

Conditions

Rheumatoid Arthritis (RA)Transcutaneous Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

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
baseline, Week 4 (end of treatment), and Week 8 (follow-up)

Secondary Outcomes (13)

Visual Analogue Scale (VAS) for pain
baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Polysymptomatic Distress Scale (PDS)
baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Brief Pain Inventory (BPI)
baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Fibromyalgia Impact Questionnaire-Revised (FIQR)
baseline, Week 4 (end of treatment), and Week 8 (follow-up)
Multidimensional Fatigue Inventory-20 (MFI-20)
baseline, Week 4 (end of treatment), and Week 8 (follow-up)
+8 more secondary outcomes

Other Outcomes (1)

Semi-Quantitative Food Frequency Questionnaire (SFFQ)
baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Hua Tuo electronic acupuncture device (Model SDZ-IIB), real auricular clips with electrodes placed bilaterally at the cavum conchae and cymba conchae; dense-disperse wave at 25 Hz, intensity set to the maximum tolerable level without pain.Twice daily, 30 minutes per session, 5 consecutive days per week, for 4 weeks total.

Device: taVNS

Control group

SHAM COMPARATOR

identical device with sham auricular clips; electrodes are placed bilaterally on the auricular scapha; all operational parameters match the experimental group. Both groups are informed that mild electrical sensations may occur.Twice daily, 30 minutes per session, 5 consecutive days per week, for 4 weeks total.

Device: Sham Stimulation

Interventions

taVNSDevice

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.

Experimental group

Sham StimulationDevice

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.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

① Meeting the 2010 ACR/EULAR classification criteria for RA;② Central Sensitization Inventory-9 (CSI-9) score ≥18 points;③ Aged 18-75 years, regardless of gender;④ Visual Analogue Scale (VAS) pain score ≥40 mm and \<90 mm at screening and randomization; subjects must complete a daily VAS pain diary for 7 consecutive days prior to randomization, with at least 4 valid records and an average daily VAS pain score ≥40 mm across valid days;⑤ Stable dosage and regimen of glucocorticoids, DMARDs, biologic agents and other basic immunotherapies for 4 weeks before enrolment, with no planned adjustments during the study;⑥ Stable dosage and regimen of analgesics (NSAIDs, pregabalin, gabapentin, etc.) for 4 weeks before enrolment, with no planned adjustments during the study;⑦ No oral Chinese herbal medicine initiated during the study, or stable oral Chinese herbal medicine for ≥4 weeks before enrolment with no planned prescription modification throughout the study;⑧ Voluntary participation in this study.

Sponsors & Collaborators

Inner Mongolia Hospital of Traditional Chinese Medicine
Type not reportedcollaborator
Shenzhen traditional Chinese medical hospital
Type not reportedcollaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

juan jiao

CONTACT

01088001030 jiao.juan@hotmail.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Chief Physician

Study Record Dates

First Submitted

October 6, 2026

First Posted

October 13, 2026

Study Start

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Other Outcomes (1)

Study Arms (2)

Experimental group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Other Outcomes (1)

Study Arms (2)

Experimental group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record