Osteoarthritis

Transcutaneous auricular vagus nerve stimulation versus sham stimulation in patients with erosive hand osteoarthritis (ESTIVAL): a randomised, multicentre, double-blind, sham-controlled trial

Lancet RheumatolPublished Randomised controlled trial

Primary result · Change in VAS hand painResult — go to the resultAdjusted between-group difference −10.0 mm 95% CI −23.0 to 2.0

Authors' 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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