Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT04520516
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Symptomatic HOA according to the American College of Rheumatology criteria
* Erosive HOA according to hand radiographs performed in routine practice showing ≥1 erosive digital joint based on Verbruggen-Veys scoring definition
* Hand pain level ≥ 40/100 mm on VAS at inclusion at least half of days of the 30 last days
* At least ≥1 symptomatic IP joint with clinical soft swelling or erythema at inclusion
* reported inadequate response or adverse effects or contraindication with existing medication (including acetaminophen, oral NSAIDs)
* Informed written consent
* Patient affiliated to a social security scheme NB: Clinical inflammation, ultrasound abnormalities and radiographic erosions have not have to be present in the same joint.
Exclusion Criteria:
* Isolated thumb-base OA (i.e., rhizarthrosis)
* Predominance of the pain in the thumb base rather than digital pain
* Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, Lyme disease)
* Psoriasis
* Current skin disease of the left ear (e.g., eczema, urticarial lesion, skin infection, external otitis)
* Ear canal not adapted to apply the auricular electrode
* Known history of cardiac rhythm disturbances, atrio-ventricular block \> first degree, or total bundle branch block
* Symptomatic orthostatic hypotension or repeated vasovagal syncope history
* History of vagotomy
* Severe Asthma
* Treated sleep apnea
* Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
* Fibromyalgia
* Use of other electrically active medical devices (e.g. pacemaker, TENS for chronic pain)
* Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the last 3 months
* Any new hand OA treatment in the previous 2 months, including physiotherapy and provision of new hand splint.
* Planned hand surgery in the next 3 months.
* Use of any investigational (unlicensed) drug within 3 months prior to screening.
* Evidence of serious uncontrolled concomitant medical condition, including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, gastro-intestinal disease or epilepsy, which in the opinion of the investigator makes them unsuitable for the study
* Pregnant or breastfeeding woman
* Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
* Use of VNS before the study
* Use of NSAIDs or paracetamol less than 48h before the D0 visit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04520516
Study Brief:
Protocol Section:
NCT04520516