TOPLINE:

Transcutaneous auricular vagus nerve stimulation (taVNS) did not significantly reduce pain in patients with erosive hand osteoarthritis compared with sham stimulation over 12 weeks but improved function and patient assessment scores. Both groups showed similar tolerance, with no serious adverse events reported.

METHODOLOGY:

• Researchers conducted a double-blind randomized controlled trial across 18 French hospital centers, including 142 adult patients with erosive hand osteoarthritis (mean age, 66.5 years; 88% women) between April 2021 and March 2022.
• Patients had hand pain for at least half a month, inadequate responses to or adverse effects from prior treatments, at least one symptomatic interphalangeal joint with clinical synovitis, and at least one erosive interphalangeal joint.
• Participants were randomly assigned to either the taVNS group (n = 73) that received daily 20-minute stimulation using the VAGUSTIM device (frequency, 25 Hz; pulse duration, 100 μsec) for 12 weeks or the sham group (n = 69) that received no electric current.
• Participants were followed up at weeks 4, 8, and 12 for conducting clinical assessments and patient surveys, monitoring adverse events, and tracking device adherence.
• The primary endpoint was the change in self-reported hand pain on a 0-100-mm visual analog scale from baseline to week 12 between the taVNS and sham groups, with safety assessed through monitoring of adverse events.

TAKEAWAY:

• At week 12, the median change on the visual analog scale for hand pain was -16.0 mm in the taVNS group vs -6.0 mm in the sham group, with a nonsignificant between-group difference of -10.0 mm (P = .22).
• The taVNS group showed a significant decrease in the mean Functional Index of Hand Osteoarthritis score compared with the sham group (between-group difference, -7.3; P = .013).
• The taVNS vs sham group also showed an improvement in the mean patient global assessment score (between-group difference, 10.7; P = .010). Paracetamol (acetaminophen) consumption was low at baseline and did not differ between groups at 12 weeks.
• No serious adverse events were observed, with 30% of patients in the taVNS group and 23% of those in the sham group experiencing nonserious adverse events, including mild local pain and dermatologic irritation.

IN PRACTICE:

“The ESTIVAL trial did not show a significant analgesic effect of taVNS in patients with erosive and inflammatory hand osteoarthritis over 12 weeks,” the authors wrote.

SOURCE:

This study was led by Alice Courties, MD, PhD, AP-HP Hôpital Saint-Antoine, Service de Rhumatologie, Sorbonne Université, Centre de Recherche Saint-Antoine in Paris, France. It was published online on December 8, 2025, in The Lancet Rheumatology.

LIMITATIONS:

This study used a sham group that received no stimulation, which may differ from other studies that used low-frequency or alternative site stimulation. Dropout rates were higher in the taVNS group than in the sham group. The study did not involve individuals with lived experience in the research process, and it lacked data on participants’ ethnicity, thereby limiting generalizability.

DISCLOSURES:

This study was funded by the French Ministry of Health and sponsored by the Assistance Publique-Hôpitaux de Paris. Some authors disclosed receiving consulting fees, travel support, honoraria, grants, or having other ties with multiple companies, including Janssen, AbbVie, and UCB.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.