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Not yet recruiting NCT07641374

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

No phase Interventional Fibromyalgia Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point..
Who it may be relevant to
Registry conditions: Fibromyalgia Syndrome. Basic parameters: 35 years — 64 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study

Overview

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

Detailed description

Participants will undergo a series of 5 weekly sessions of auricular acupuncture using semi-permanent needles (Pyonex Seirin 0.9 mm). The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. Each application will last for 72 hours, with the patient performing the removal

Interventions

  • Device The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point.
    Participants will undergo a series of 5 weekly sessions of auricular acupuncture using semi-permanent needles (Pyonex Seirin 0.9 mm). The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. Each application will last for 72 hours, with the patient performing the removal

Primary outcome measures

  • Change from Baseline in Autonomic Nervous System (ANS) Balance via LF/HF Ratio [Time frame: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4), and Follow-up at Week 8 (T5).]
Secondary outcome measures (1)
  • Change from baseline in Pressure Pain Threshold (PPT) [Time frame: Baseline (T0), Week 2 (T2), Week 4 (T4), and Week 8 (T5)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Pain Therapy Clinic, Lonigo (VI) — Lonigo

Identifiers

NCT: NCT07641374 · AIRAS-FIBRO-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗