Clinical trial: Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis (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

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment