Auricular acupuncture to balance autonomic function and pain in fibromyalgia
Official title: Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study
Run by Italian Association for the Research and the Scientific Update · NCT07641374 · Data updated 2026-11-12
This study tests whether semi-permanent ear acupuncture can improve autonomic regulation and pain sensitivity in adult women with fibromyalgia over five weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 64 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Italian Association for the Research and the Scientific Update Academic / other |
| Locations | 1 site (Lonigo, VICENZA) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07641374 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 35-64 with fibromyalgia diagnosed by ACR 2016 criteria who consent to the procedure and have no exclusions related to cardiac rhythm disorders or certain medications.
✕Probably not a fit
Individuals with pacemakers, significant cardiac rhythm disorders, COPD, or on medications that markedly affect autonomic responses may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls adult female participants with fibromyalgia to receive a five-week course of semi-permanent auricular acupuncture using Pyonex Seirin needles placed on four ear points. Each needle remains in place for 72 hours, with a total of five weekly sessions. The trial will measure changes in autonomic nervous system activity and pressure pain threshold to assess the treatment's impact on autonomic balance and pain sensitivity. Participants are evaluated according to 2016 ACR criteria and must not have conditions or medications that could confound autonomic responses. The study is conducted at a pain therapy clinic in Lonigo, Italy, led by the Italian Association for Research and Scientific Update.
Why it matters
Potential benefit: If successful, participants may experience improved autonomic balance and reduced pain sensitivity.
How similar studies have gone: While auricular acupuncture has shown signals of autonomic and pain-related effects in some studies, this exact semi-permanent ear-needle approach in fibromyalgia is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Pain Therapy Clinic, Lonigo (VI)
Lonigo, Vicenza, Italy Recruiting
Study contacts
- Study coordinator: Antonello Lovato, MD
- Email: lovatoantonello@gmail.com
- Phone: +00390444832740
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.