Hand Osteoarthritis Clinical Trial
— ADEPTOfficial title:
Transcutaneous Auricular Vagus Nerve Stimulation in Erosive Hand Osteoarthritis
Verified date | April 2020 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 16, 2019 |
Est. primary completion date | December 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Rheumatology department Saint-Antoine Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Function | 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 |
1 month | |
Secondary | Side effect | Safety : report of side effects during the study period | 1 month | |
Secondary | 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 | |
Secondary | Dose of daily consumption of paracetamol | Measure of Pain by daily consumption of paracetamol | 1 month |
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