MedTrace Logo

Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis

NCT04520516 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-09-16

No results posted yet for this study

Summary

Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability.

Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level.

ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA.

tVNS will be performed using a transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve.

The active and sham device's will display similar appearance but the sham one will not give electric signal.

Conditions

Interventions

DEVICE

Active VAGUSTIM device

Settings: 25 Hz stimulation, 100 microsec pulse width, intensity escalation up to 8 mA or below if tingling sensation, 20 min/day of stimulation in one daily session

DEVICE

Sham VAGUSTIM device

The sham device : no electrical signal for VNS will be delivered.

Sponsors & Collaborators

  • Schwa medico (device lending)

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jérémie SELLAM, Professor · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-08
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04520516 on ClinicalTrials.gov