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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active arm with active tVNS for 1 month | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Pain | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Function | questionnaire Functional Index for Hand OsteoArthritis (FIHOA): scale minimum 0 , and maximum 30. Scoring system of the FIHOA: 0 = possible without difficulty
| 1 month |
| Side effect |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jérémie Sellam, MD PhD PUPH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology department Saint-Antoine Hospital | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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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 | 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 | Measure of Pain by daily consumption of paracetamol | 1 month |