Trial reportRMD open2023
Transcutaneous auricular branch vagal nerve stimulation as a non-invasive add-on therapeutic approach for pain in systemic sclerosis.
Trial report in RMD open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Assessing the therapeutic potential of vagus nerve stimulation in autoimmune diseases: A systematic review.Physiological reports · 2025Pooled it
- Effect of transcutaneous vagus nerve stimulation in hemodialysis patients: A randomized controlled trial.Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy · 2026Trial
- Ameliorating Effects and Autonomic Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain in Patients With Functional Dyspepsia and Irritable Bowel Syndrome.Neurogastroenterology and motility · 2026Trial
- Activation of the Cerebrospinal Fluid-Contacting Nucleus Mitigates Systemic Inflammation Induced by Sepsis.Shock (Augusta, Ga.) · 2026Article
- Association ofInternational journal of molecular sciences · 2026Article
- A Review of Vagus Nerve Stimulation for Disease: Comprehensive Theory and Evidence for Mechanisms of Action.Comprehensive physiology · 2026Review
- Short and long term effects of a two-week transcutaneous vagus nerve stimulation in hyperadrenergic postural orthostatic tachycardia syndrome: a proof-of-concept trial.European journal of internal medicine · 2026Article
- The role of transcutaneous auricular vagus nerve stimulation in chronic pain: from neurobiological mechanisms to clinical applications.Frontiers in pain research (Lausanne, Switzerland) · 2026Review
- Research Progress of Transcutaneous Auricular Vagus Nerve Stimulation in Chronic Pain Management: A Narrative Review.Journal of pain research · 2026Review
- Vagus nerve stimulation: a novel approach for refractory rheumatoid arthritis.Clinical rheumatology · 2026Article
- Enteric neuropathy and the vagus nerve: Therapeutic implications.Neurogastroenterology and motility · 2025Review
- Heart Rate Variability, Microvascular Dysfunction, and Inflammation: Exploring the Potential of taVNS in Managing Heart Failure in Type 2 Diabetes Mellitus.Biomolecules · 2025Review
- Cardiac vagal control and inflammation are upregulated in exceptional human longevity.Internal and emergency medicine · 2025Article
- Vagus nerve stimulation for chronic pain management: Mechanisms and clinical advances.Journal of biological methods · 2025Review
- Vagus nerve stimulation (VNS): recent advances and future directions.Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024Review
- Transcutaneous vagus nerve stimulation effects on chronic pain: systematic review and meta-analysis.Pain reports · 2024Review
- Article
- Managing gastrointestinal manifestations in systemic sclerosis, a mechanistic approach.Expert review of clinical immunology · 2024Review
- Is the vagus nerve the "MVP" in the brain-body axis?Clinical autonomic research : official journal of the Clinical Autonomic Research Society · 2024Article
- Non-invasive vagus nerve stimulation in anti-inflammatory therapy: mechanistic insights and future perspectives.Frontiers in neuroscience · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSystemic sclerosis (SSc) is an autoimmune disease with health-related quality of life (HRQoL) high impairment. Pain is of paramount importance to be targeted by therapeutical approaches. Our study aim was to perform an add-on device-based non-invasive neuromodulatory treatment through transcutaneous auricular vagal nerve stimulation (tVNS) in patients with SSc, assessing its effects on pain as primary endpoint and on inflammation, cardiovascular autonomic control and HRQoL.
methodsThirty-two patients with SSc were enrolled based on reported pain assessed through Numeric Rating Scale (NRS). Twenty-one (90% with limited cutaneous SSc) completed a randomised, cross-over, patient-blind trial, in which interventional and active control were used in random order for 4 weeks, interspersed with 4 weeks washout. NRS, Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Item4 for pain interference, heart rate variability (HRV), serum cytokines and HRQoL questionnaires (Health Assessment Questionnaire, Patient Health Questionnaire-9, University of California, Los Angeles Gastrointestinal Tract, Pittsburgh Sleep Quality Index) were assessed at baseline, at T1 (after 1 month of tVNS or active control), at T2 (after washout) and at T3 (after 1 month of active control or tVNS). T-test for paired data and Wilcoxon signed-rank test for non-normally distributed parameters were performed to compare the effect of tVNS and active control.
resultsNRS pain was significantly reduced by tVNS and not by active control (Mean±SD: -27.7%±21.3% vs -7.7%±26.3%, p=0.002). Interleukin-6 was downregulated in tVNS versus active control (p=0.029). No significant differences were observed in tVNS versus active control for PROMIS-29 Item4, QoL scales and HRV with both spectral and symbolic analyses.
conclusiontVNS demonstrated to be a safe and non-invasive add-on tool to reduce pain in SSc.
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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.