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

April 8, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Rheumatology department Saint-Antoine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month
Side effect
Time Frame: 1 month
Safety : report of side effects during the study period
1 month
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
1 month
Dose of daily consumption of paracetamol
Time Frame: 1 month
Measure of Pain by daily consumption of paracetamol
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jérémie Sellam, MD PhD PUPH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2020

Last Update Submitted That Met QC Criteria

April 8, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe