Ear zap may calm lupus pain by taming inflammation

NCT ID NCT02822989

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether a small device that gently stimulates a nerve in the ear can reduce muscle and joint pain in people with lupus. The idea is to activate the body's natural 'cholinergic anti-inflammatory pathway' to lower inflammation. Participants use the device for 5 minutes daily over 4 days, and researchers measure pain changes and side effects.

What this could mean

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

Active substance
transcutaneous auricular vagus nerve stimulation (tVNS) device
What this could lead to
If it works, this could offer a drug-free way to ease lupus-related muscle and joint pain by tapping into the body's natural anti-inflammatory system.
What could go wrong
This is a very small early study with only 19 people, so results may not apply widely. The pain relief might be modest or no better than a sham device.

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

19 people

The number who actually took part.

Started

Nov 2017

Finished

Nov 2020

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: 1. Age ≥18 years, 2. SLE (defined by the ACR or SLICC criteria), 3. Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale 4. BILAG C on Musculoskeletal Domain of the BILAG 2004 5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline, 6. If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline 7. Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: 1. Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion), 2. Treatment with cyclophosphamide within 2 months of baseline, 3. Expectation to increase steroids and/or immunosuppressive treatment, 4. Anti-phospholipid syndrome, 5. Fibromyalgia (fibromyalgia will be defined as a score \> 13 on the Fibromyalgia Symptom Scale (FSS). 6. Treatment with an anti-cholinergic medication, including over the counter medications, 7. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. 8. Current tobacco or nicotine user, 9. Joint replacement within 60 days prior to study enrollment or planned within the course of the study, 10. Any planned surgical procedure requiring general anesthesia within the course of the study, 11. Intra-articular cortisone injections within 28 days of the start of study, 12. Chronic inflammatory disorders apart from SLE affecting the joints, 13. Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time, 14. Active infection including hepatitis B or hepatitis C at baseline, 15. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention, 16. Pregnancy or lactation, 17. Comorbid disease that may require administration of corticosteroid use, 18. Inability to comply with study and follow-up procedures.

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Conditions

The condition(s) this trial relates to.

Inflammation Musculoskeletal Pain systemic lupus erythematosus

As listed by the trial registrant

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

Contacts and locations

Locations

  • Feinstein Institute

    Manhasset, New York, 11030, United States

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