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Treatment of Erosive Digital Osteoarthritis by Transcutaneous Auricular Nerve Stimulation (ADEPT)

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ClinicalTrials.gov Identifier: NCT03919279
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Erosive Osteo-Arthritis Hand Osteoarthritis Device: active tVNS Not Applicable

Detailed Description:

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: active arm with active tVNS for 1 month Device: active tVNS
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 Outcome Measures :
  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 Outcome Measures :
  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

    1. = possible with slight difficulty
    2. = possible with important difficulty
    3. = 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919279


Contacts
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Contact: Jérémie Sellam, MD PhD PUPH + 33 1 49 28 25 20 jeremie.sellam@aphp.fr
Contact: Alice COURTIES, MD Assistant professor + 33 1 49 28 25 20 alice.courties@aphp.fr

Locations
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France
Rheumatology department Saint-Antoine Hospital Recruiting
Paris, France, 75012
Contact: Jérémie Sellam, Md PhD PU-PH    + 33 1 49 28 25 20    jeremie.sellam@aphp.fr   
Contact: Alice Courties, MD Assistant professor    + 33 1 49 28 25 20    alice.courties@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jérémie Sellam, MD PhD PUPH Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03919279     History of Changes
Other Study ID Numbers: APHP190156
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Erosive hand osteoarthritis
pain
inflammation
vagus nerve stimulation

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases