Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis

NCT04520516 | Completed

• 1 other identifier: APHP200014
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis; Musculoskeletal Pain; Erosive Osteoarthritis

Keywords

Musculoskeletal pain; Osteoarthritis; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change from Day 0 to Week 12 of self-reported hand pain

  Change from Day 0 to Week 12 of self-reported hand pain in the previous 48 hours measured on a 100 mm visual analogue scale (VAS) : "How much pain in your hands did you experience during the past 48 h?"

  12 weeks

Secondary Outcomes (22)

• AUStralian CANadian Osteoarthritis Hand Index (AUSCAN)(pain, function, stiffness).

  Between week 0 and week 12

• Modified Functional Index for Hand OsteoArthritis (FIHOA)

  Between week 0 and week 12 vvv

• Cochin Hand Function Scale.

  Between week 0 and week 12

• Percentage of patients below the Patient Acceptable Symptom State (PASS) of pain (VAS<40/100)

  Between week 0 and week 12

• EuroQoL EQ-5D.

  Between week 0 and week 12

Other Outcomes (5)

• W0-W12 change in the WOMAC for other osteoarthritis sites (hips, knees) if present at inclusion.

  Between week 0 and week 12

• Effectiveness of the blinding procedure and the ease of use of the device

  Week 12

• Change in HOAMRIS subscores of synovitis and subchondral bone marrow edema using MRI examination

  Between week 0 and week 12

Study Arms (2)

tVNS active device

EXPERIMENTAL

VAGUSTIM device from Schwa-Medico Length of use : 12 weeks

Device: Active VAGUSTIM device

Sham tVNS device

SHAM COMPARATOR

Sham VAGUSTIM device from Schwa-Medico Length of use : 12 weeks

Device: Sham VAGUSTIM device

Interventions

Active VAGUSTIM device 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

tVNS active device

Sham VAGUSTIM device DEVICE

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

Sham tVNS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Symptomatic HOA according to the American College of Rheumatology criteria
• Erosive HOA according to hand radiographs performed in routine practice showing ≥1 erosive digital joint based on Verbruggen-Veys scoring definition
• reported inadequate response or adverse effects or contraindication with existing medication (including acetaminophen, oral NSAIDs)
• Informed written consent
• Patient affiliated to a social security scheme NB: Clinical inflammation, ultrasound abnormalities and radiographic erosions have not have to be present in the same joint.

You may not qualify if:

• Isolated thumb-base OA (i.e., rhizarthrosis)
• Predominance of the pain in the thumb base rather than digital pain
• Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, Lyme disease)
• Psoriasis
• Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection, external otitis)
• Ear canal not adapted to apply the auricular electrode
• Known history of cardiac rhythm disturbances, atrio-ventricular block \> first degree, or total bundle branch block
• Symptomatic orthostatic hypotension or repeated vasovagal syncope history
• History of vagotomy
• Severe Asthma
• Treated sleep apnea
• Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
• Fibromyalgia
• Use of other electrically active medical devices (e.g. pacemaker, TENS for chronic pain)
• Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the last 3 months

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Schwa medico (device lending): collaborator

Study Sites (1)

Service de Rhumatologie - Hôpital Saint Antoine

Paris, 75012, France

Location

Related Publications (2)

• Courties A, Tuffet S, Cormier G, Roux CH, Ornetti P, Pers YM, Gottenberg JE, Lespessailles E, Chapurlat R, Arniaud D, Rannou F, Wendling D, Eymard F, Mathieu S, Richette P, Saraux A, Marotte H, Poursac N, Rat AC, Bastard JP, Fellahi S, Henrotin Y, Minssen L, Deprouw C, Nguyen C, Touati A, Berard L, Rousseau A, Simon T, Maheu E, Berenbaum F, Sellam J. 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. 2025 Dec 8:S2665-9913(25)00226-7. doi: 10.1016/S2665-9913(25)00226-7. Online ahead of print.

  PMID: 41380709 DERIVED

• Courties A, Deprouw C, Rousseau A, Berard L, Touati A, Kalsch J, Villevieille M, Maheu E, Miquel A, Simon T, Berenbaum F, Sellam J; ESTIVAL study group. Transcutaneous vagus nerve stimulation in erosive hand osteoarthritis: protocol for the randomised, double-blind, sham-controlled ESTIVAL trial. BMJ Open. 2022 Mar 22;12(3):e056169. doi: 10.1136/bmjopen-2021-056169.

  PMID: 35318234 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jérémie SELLAM, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: April 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 16, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)