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Ear zap device tested for arthritis hand pain

NCT ID NCT04520516

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a device that gently stimulates a nerve in the ear to reduce pain and inflammation in people with a severe form of hand osteoarthritis. 148 participants used either the active device or a sham (fake) device daily for 12 weeks. The goal was to see if the real device could lower hand pain more than the placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
auricular transcutaneous vagus nerve stimulation (tVNS) device
What this could lead to
If it works, this could offer a non-drug, at-home option to ease hand pain and inflammation for people with erosive hand osteoarthritis.
What could go wrong
This is a small, early-stage trial with no phase designation. The sham device looks identical but delivers no stimulation, so any benefit may be due to placebo. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

148 people

The number who actually took part.

Started

Apr 2021

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Service de Rhumatologie - Hôpital Saint Antoine

    Paris, 75012, France

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Other studies related to the condition(s) this trial covers.