Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

NCT07641374 | Not Yet Recruiting DMC

• 1 other identifier: AIRAS-FIBRO-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fibromyalgia Syndrome

Keywords

Ear acupuncture; Heart Rate Variability (HRV); pressure pain threshold; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

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

  Evaluated through Photoplethysmography (PPG) using the PPG Stress Flow device. The autonomic nervous system balance is expressed specifically by the Low Frequency to High Frequency (LF/HF) ratio. Other spectral parameters (SDNN and HF power) are collected simultaneously to support the comprehensive Heart Rate Variability (HRV) analysis. All measurements are taken immediately before each acupuncture session.

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

Secondary Outcomes (1)

• Change from baseline in Pressure Pain Threshold (PPT)

  Baseline (T0), Week 2 (T2), Week 4 (T4), and Week 8 (T5)

Study Arms (1)

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia.

EXPERIMENTAL

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

Device: The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point.

Interventions

The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. DEVICE

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

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia.

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: FEMALE
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Italian Association for the Research and the Scientific Update: lead

Study Sites (1)

Pain Therapy Clinic, Lonigo (VI)

Lonigo, VICENZA, 36045, Italy

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Antonello Lovato, MD

CONTACT

+00390444832740; lovatoantonello@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor and Research Coordinator

Model Details: 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

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)