Evidence map›Paper›PMID 42423822›Full record

Trial reportClinical rheumatology2026

Sacral nerve stimulation modulates disease activity and autonomic function in active rheumatoid arthritis: a randomized pilot study.

Xiaoqin Wang, Bingguo Xu, Guoxin Wang, Leilei Yang, Dinglei Su, Jiande D Z Chen

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Clinical rheumatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04821050 (A Randomized, Sham-Controlled, Double-Blind Study of Sacral Nerve Stimulation for Mild-to-Moderate or Refractory Rheumatoid Arthritis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04821050 naunknown statusnot on this map

A Randomized, Sham-Controlled, Double-Blind Study of Sacral Nerve Stimulation for Mild-to-Moderate or Refractory Rheumatoid Arthritis

TypeinterventionalSponsorNanjing First Hospital, Nanjing Medical UniversityRan2021 to 2022Enrolled60ConditionsRheumatoid ArthritisArmsSacral nerve stimulation, Sham stimulation
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Xiaoqin Wang *Department of Rheumatology and Immunology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Bingguo Xu *Department of Traditional Chinese Medicine and Acupuncture, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Guoxin WangDepartment of Traditional Chinese Medicine and Acupuncture, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Leilei YangDepartment of Rheumatology and Immunology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Dinglei SuDepartment of Rheumatology and Immunology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. sudinglei@163.com.ORCID http://orcid.org/0000-0002-8573-3275
Jiande D Z ChenDivision of Gastroenterology and Hepatology, University of Michigan School of Medicine, Ann Arbor, MI, 48109, USA.

Funding

International Cooperation Project of Nanjing Municipal Science and Technology Bureau 202002053
6 · The paper itself

Abstract

objectiveTo evaluate the feasibility and safety as well as potential effects of percutaneous sacral nerve stimulation (SNS) via acupuncture needles in patients with active rheumatoid arthritis (RA).

methodsTwenty-one patients with active RA were allocated to receive either active SNS (n = 11) or sham stimulation (n = 10) for 60 min daily over 14 days. Primary outcomes were changes in disease activity, assessed by the Disease Activity Score in 28 joints (DAS-28), tender joint count (TJC), swollen joint count (SJC), pain intensity on a visual analogue scale (VAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). Secondary outcomes included the following: (1) patient-reported outcomes for joint function, fatigue, anxiety, and depression; (2) serum levels of inflammatory cytokines; and (3) heart rate variability (HRV) parameters as a measure of autonomic function.

resultsIn this pilot study, the SNS group showed significant within-group improvements in TJC, VAS, DAS28-ESR, and DAS28-CRP. However, an analysis of covariance (ANCOVA) adjusting for baseline values revealed no significant between-group differences in clinical and inflammatory parameters. The SNS group showed a significant increase in rMSSD (parasympathetic marker), with the between-group difference sustained after baseline adjustment. No significant differences were observed in functional and psychological scores or serum cytokine levels between the two groups.

conclusionThis first-in-human study indicates that percutaneous SNS is feasible and safe, with a possible modulatory effect on autonomic function in active RA. Further large‑scale, adequately powered trials are warranted to confirm the clinical efficacy and mechanisms of SNS in RA.

trial registrationThis study was registered at ClinicalTrials.gov on March 25, 2021 under the identifier NCT04821050 (Protocol ID: 202002053). Key Points • First-in-human pilot study of percutaneous sacral nerve stimulation (SNS) in active RA. • SNS was associated with significant within-group improvements in tender joint count, pain VAS, and DAS28, but between-group differences did not reach statistical significance after baseline adjustment. • SNS significantly enhances parasympathetic activity (rMSSD) compared with sham stimulation, an effect that remained significant after adjusting for baseline differences. • Percutaneous SNS was safe and well-tolerated, with no serious adverse events reported.

Indexed as

Acupuncture TherapyArthritis, RheumatoidAutonomic Nervous SystemLumbosacral PlexusAdultAgedFemaleHeart RateHumansMaleMiddle AgedPain MeasurementPilot ProjectsSeverity of Illness IndexTreatment OutcomeAutonomic nervous systemHeart rate variabilityNeuromodulationRheumatoid arthritisSacral nerve stimulation

Identifiers

PMID42423822

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.