Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia

ConditionFibromyalgia Syndrome

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age35-64

SponsorItalian Association for the Research and the Scientific Update

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female sex.

Aged between 35 and 64 years.

Signed written informed consent.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia.Experimental treatment 1 intervention

Trial 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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Italian Association for the Research and the Scientific Update

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: