Not Yet RecruitingNot Applicable

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

Italy30 participantsStarted 2026-06-01

Plain-language summary

This longitudinal study evaluates the effects of semi-permanent auricular acupuncture on the Autonomic Nervous System (ANS) activity and pressure pain threshold in adult female patients (aged 35-64) diagnosed with Fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria. The study aims to investigate how a 5-week treatment cycle influences cardiac autonomic regulation and pain sensitivity

Who can participate

Age range

35 Years – 64 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Confirmed diagnosis of Fibromyalgia by a Rheumatologist according to the 2016 ACR (American College of Rheumatology) criteria. * Female sex. * Aged between 35 and 64 years. * Signed written informed consent. Exclusion Criteria: * Presence of cardiac rhythm disorders such as permanent Atrial Fibrillation. * Patients with Pacemakers. * Subjects affected by Chronic Obstructive Pulmonary Disease (COPD) * Patients taking continuous medications that can alter the autonomic response (e.g., beta-blockers, antiarrhythmics, inhaled beta2-agonists). * Subjects with specific contraindications to auricular acupuncture.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still in the 'not yet recruiting' phase — do you know when it's expected to open, and would it even make sense for me to wait for it given where I am in my fibromyalgia treatment right now?
2The trial is measuring something called the LF/HF ratio to track autonomic nervous system balance — can you help me understand what that means for fibromyalgia, and whether changes in that measurement would actually translate to feeling better day to day?
3Since this is listed as Phase NA, which often applies to non-drug studies, what do we know about the safety and evidence base for auricular acupuncture in fibromyalgia before I consider joining a trial that's still building that knowledge?
4Are there standard or established treatments for my fibromyalgia that I should try first, or is my situation one where exploring something like this trial alongside conventional care might make sense to discuss?
5What would participation actually look like for me in terms of time, appointments, and whether I'd need to pause or change any current medications or therapies I'm already using for fibromyalgia?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Autonomic Nervous System (ANS) Balance via LF/HF Ratio

Timeframe: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4), and Follow-up at Week 8 (T5).

Trial details

NCT IDNCT07641374

SponsorItalian Association for the Research and the Scientific Update

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Antonello Lovato, MD

+00390444832740 lovatoantonello@gmail.com

View on ClinicalTrials.gov More Fibromyalgia Syndrome trials