Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

N/ANot Yet RecruitingNCT07641374

Italian Association for the Research and the Scientific Update30 enrolled

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia Syndrome

Interventions

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

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pain Therapy Clinic, Lonigo (VI)

Lonigo, VICENZA, Italy

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Change from baseline in Pressure Pain Threshold (PPT)

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

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

Central Contacts

Antonello Lovato, MD

CONTACT

+00390444832740 lovatoantonello@gmail.com

Data from ClinicalTrials.gov

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