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NCT Number: NCT07641374

Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

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

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Key information

Conditions

Fibromyalgia Syndrome Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

35 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Change from baseline in Pressure Pain Threshold (PPT)

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

    Measured using the Force Ten FPX 25 Algometer to determine the minimum pressure perceived as painful. Measurements are taken at three specific body points: Trapezius (GB21), Lateral Epicondyle (LI11), and below the knee (ST36). Measurements are taken immediately before the acupuncture session

Study contacts

Contact information is provided by the study sponsor or research team.

Antonello Lovato, MD

CONTACT

[email protected]

+00390444832740

Sponsors and collaborators

Lead sponsor

Italian Association for the Research and the Scientific Update

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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