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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- Measure of Pain [ Time Frame: 1 month ]
Self-reported hand pain in the previous 48h measured on a 100 mm visual analogic scale (VAS).
0= No pain 5= Moderate pain 10= Worst pain
- 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
- Side effect [ Time Frame: 1 month ]Safety : report of side effects during the study period
- 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
- Dose of daily consumption of paracetamol [ Time Frame: 1 month ]Measure of Pain by daily consumption of paracetamol
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
|Contact: Jérémie Sellam, MD PhD PUPH||+ 33 1 49 28 25 firstname.lastname@example.org|
|Contact: Alice COURTIES, MD Assistant professor||+ 33 1 49 28 25 email@example.com|
|Rheumatology department Saint-Antoine Hospital||Recruiting|
|Paris, France, 75012|
|Contact: Jérémie Sellam, Md PhD PU-PH + 33 1 49 28 25 20 firstname.lastname@example.org|
|Contact: Alice Courties, MD Assistant professor + 33 1 49 28 25 20 email@example.com|
|Principal Investigator:||Jérémie Sellam, MD PhD PUPH||Assistance Publique - Hôpitaux de Paris|