Status:
UNKNOWN
Sacral Nerve Stimulation for Mild-to-Moderate or Refractory Rheumatoid Arthritis
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This pilot study will assess the efficacy of sacral never stimulation (SNS) for the treatment of adult patients with active, mild-to-moderate rheumatoid arthritis or those with refractory disease. The...
Detailed Description
Studies have shown that vagus nerve stimulation (VNS) may exert an anti-inflammatory effect through mechanisms like cholinergic anti-inflammatory pathway (CAP). This anti-inflammatory function of VNS ...
Eligibility Criteria
Inclusion
- 18-65 years of age at screening
- Met the American College of Rheumatology criteria (2010) for RA
- Active mild to moderate RA (defined as 3.2 \< DAS28-CRP\< 5.1) naïve to any medication; or refractory RA who demonstrated an inadequate response or loss of response to 2 or more conventional synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) after treatment for at least 6 months.
Exclusion
- Any severe chronic or uncontrolled comorbid disease, such as important organ failure, degree II and III heart block, clinically significant cardiovascular disease, severe infection, tumor, etc;
- Combined with other connective tissue diseases
- Cognitive impairment and can't cooperate
- Pregnancy or breastfeeding
- Bleeding or coagulation disorders
- Localized skin infections
- Intra-articular corticosteroid or pulse steroid within 2 weeks preceding the study
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04821050
Start Date
March 1 2021
End Date
December 1 2022
Last Update
March 4 2022
Active Locations (1)
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1
Dinglei Su
Nanjing, Jiangsu, China, 210006