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Can a nerve zap in the neck tame fibromyalgia pain?

NCT ID NCT06237595

Symptom relief Sponsor: Kasr El Aini Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study tests whether a noninvasive device that stimulates the vagus nerve can reduce pain and other symptoms in women with fibromyalgia. Participants will receive either the nerve stimulation, standard medical treatment, or both, to see which approach works best. The goal is to find a new way to ease the widespread pain, fatigue, and emotional distress that come with fibromyalgia.

What this could mean

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

Active substance
Noninvasive vagus nerve stimulation (electrical stimulation of the vagus nerve) compared to and combined with standard medical treatment
What this could lead to
If effective, this could offer a drug-free option or add-on to help manage fibromyalgia pain and related symptoms like anxiety and depression.
What could go wrong
This is a relatively small study, and results may not apply to all fibromyalgia patients. The treatment may not prove more effective than standard care, and individual responses can vary.

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

87 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2025

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 to 55 years

Sex

Female participants only

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: * Female patients above 18 years, with a clinical diagnosis of fibromyalgia according to 2016 ACR fibromyalgia diagnostic criteria, will be included in this study. Exclusion Criteria: * \- Pregnant, and postmenopausal women. * Patients with any medical disorder including: cardiovascular, pulmonary, renal, hepatic, endocrine, blood, gastrointestinal, diabetes, neuropathic disorders, psychiatric disorders (for example; post traumatic stress disorder (PTSD), mania, psychosis, suicidality, bipolar/schizophrenia/autism spectrum disorders) and/or neurodegenerative disorders (e.g., Parkinson's, Alzheimer's, Huntington's disease). * Cancer diagnosis within the preceding 5 years. * Planned surgery. * Use of other medical devices electrically active for example a cardiac pacemaker, or TENS for chronic pain. * Electrocardiogram (ECG) abnormalities. * History of Electroconvulsive therapy (ECT). * Symptomatic orthostatic hypotension, or history of recurrent vagal syncope. * History of vagotomy. * Uncontrolled hypertension or hypotension. * Documented sleep apnea. * Other rheumatic diseases like (Rheumatoid Arthritis, Systemic lupus erythematosus, Seronegative spondyloarthropathies).

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia

As listed by the trial registrant

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

Fibromyalgia

Contacts and locations

Locations

  • Kasr Elainy Hospital

    Cairo, Cairo Governorate, 11562, Egypt

More trials for these conditions

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