Transcutaneous auricular vagus nerve stimulation versus sham stimulation in patients with erosive hand osteoarthritis (ESTIVAL): a randomised, multicentre, double-blind, sham-controlled trial
Primary result · Change in VAS hand painResult — go to the resultAdjusted between-group difference −10.0 mm 95% CI −23.0 to 2.0Authors' conclusion
In participants with erosive hand osteoarthritis, taVNS was safe and well tolerated.
Study context
- Population
- Adults fulfilling ACR criteria for hand OA with ≥1 erosive interphalangeal joint and US-confirmed synovitis, 18 French hospital centres148 enrolled
- Participants
- 142 adults
- Comparison
- Daily 20-min transcutaneous auricular vagus nerve stimulation (taVNS) vs sham stimulation for 12 weeks
- taVNSn = 73
- Shamn = 69reference
- Primary endpoint
- Change in hand pain visual analogue scale (VAS) from baseline to week 12
- Follow-up
- Week 12
Methodological detailsmulticentre, double-blind, sham-controlled
- Multicentre
- Double-blind
- Sham-controlled
Primary result
Change in VAS hand pain
Adjusted between-group difference
−10.0 mm
95% CI −23.0 to 2.0
P = 0.22
Change by group
taVNS
−16.0
median · IQR −32.0–5.0 · mm
Sham
−6.0
median · IQR −27.0–7.0 · mm
taVNSvs Sham
adjusted between-group difference −10.0 mm (95% CI −23.0 to 2.0); P = 0.22
As reported in the abstract
Safety
Adverse events · no emerging safety concerns
Serious adverse events
- No serious adverse events occurred
Original publication
Transcutaneous auricular vagus nerve stimulation versus sham stimulation in patients with erosive hand osteoarthritis (ESTIVAL): a randomised, multicentre, double-blind, sham-controlled trial. Lancet Rheumatol. Published 8 December 2025. doi:10. 1016/ s2665-9913(25)00226-7
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