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Completed

NCT Number: NCT03919279

Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation

Erosive hand osteoarthritis (EHOA) is a subtype of had osteoarthritis characterized by inflammation and pain, with subsequent burden. Few symptomatic treatments are available in EHOA, while this population with EHOA has frequently comorbidities.

Stimulation of the vagus nerve (VN), belonging to parasympathetic system, dampens pro-inflammatory cytokines production by splenic macrophages, through to the binding of acetylcholine neurotransmitter to α7nicotinic receptor on macrophages: this is the cholinergic anti-inflammatory pathway (CAP). Beyond its anti-inflammatory effects, VNS is analgesic in chronic pain disorders (headache, fibromyalgia). Beside implantable devices, VNS may be performed using transcutaneous stimulation of the ascendant auricular branch of the VN (tVNS) at the left ear localized on the cymba conchae tVNS is well-tolerated therapy avoiding invasive neurosurgery.

The investigator do the hypothesis that auricular tVNS using a transcutaneous electrical nerve stimulation (TENS) device could be a novel, simple and well-tolerated analgesic and anti-inflammatory treatment of symptomatic EHOA.

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Key information

Conditions

Erosive Osteo-Arthritis Hand Osteoarthritis Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rheumatology department Saint-Antoine Hospital

Paris, 75012, France

About this study

In symptomatic and inflammatory EHOA patients, we will apply tNVNS using device from Schwa-Medico (TENSeco2 + auricular electrode + conductive gel) 25 Hz stimulation will be applied, intensity escalated up to 15 mA or below if tingling sensation.

tVNS will be performed 1 hour daily for 1 month and we will assess EHOA symptoms (pain and function) at 1 month (end of the study)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18 years
  • Symptomatic HOA (1990 American College of Rheumatology criteria)
  • EHOA according to hand radiographs with ≥1 erosive digital joints of proximal or distal interphalangeal joint (phases "E" or "R" of Verbruggen-Veys score)
  • Visual Analogic Scale (VAS) for hand pain ≥ 40/100 at inclusion

-≥1 interphalangeal joints symptomatic ≥ 3 months despite analgesics or non-steroidal anti-inflammatory drugs (NSAIDs) (or contraindicated)

  • ≥1 symptomatic interphalangeal joint with clinical palpable synovitis at inclusion
  • Informed written consent

Exclusion criteria

  • Isolated thumb-base OA (ie, rhizarthrosis)
  • Hand osteoarthritis secondary to other known causes (eg gout, psoriatic arthritis)
  • Psoriasis
  • Current skin disease of the ear
  • Ear canal not adapted to apply the auricular electrode
  • History of severe cardiac disease (coronary artery disease, rhythm disturbance, heart failure, valvulopathy)
  • Conduction or rhythm disturbances on electrocardiogram
  • Symptomatic orthostatic hypotension or vasovagal syncope history
  • History of vagotomy
  • Pregnancy
  • Fibromyalgia
  • Use of other electrically active medical devices (eg pacemaker)
  • Documented sleep apnea
  • Use of corticosteroid (oral, intramuscular, intra-articular or intravenous), immunosuppressive agents, hyaluronic acid injection in interphalangeal joint within the last 3 months
  • Hand surgery planned during the study period
  • Pregnancy or breastfeeding if applicable
  • Oral NSAIDs consumption during the last 48 hours before inclusion

Treatment and study plan

active tVNS

Device

tVNS using TENS device from Schwa-Medico (TENSeco2) + auricular electrode applied on the left ear (Schwa-Medico) + conductive gel class I; 25 Hz stimulation 1 hour daily for 1 month

Primary outcomes

  1. Measure of Pain

    Time frame: 1 month

    Self-reported hand pain in the previous 48h measured on a 100 mm visual analogic scale (VAS).

    Scoring system:

    0= No pain 5= Moderate pain 10= Worst pain

Secondary outcomes

  1. Function

    Time frame: 1 month

    questionnaire Functional Index for Hand OsteoArthritis (FIHOA): scale minimum 0 , and maximum 30.

    Scoring system of the FIHOA:

    0 = possible without difficulty

    • = possible with slight difficulty
    • = possible with important difficulty
    • = impossible

  2. Side effect

    Time frame: 1 month

    Safety : report of side effects during the study period

  3. Mean time of daily use and cumulative time of use from the device's tracker

    Time frame: 1 month

    Observance : Mean time of daily use and cumulative time of use during the 30 days before the 1 month visit collected from the device's tracker

  4. Dose of daily consumption of paracetamol

    Time frame: 1 month

    Measure of Pain by daily consumption of paracetamol

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis

Acronym: ADEPT

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2019
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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