Fibromyalgia Syndrome
Conditions
Keywords
Ear acupuncture, Heart Rate Variability (HRV), pressure pain threshold, Fibromyalgia
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
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
DEVICEThe 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
Sponsors
Italian Association for the Research and the Scientific Update
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Autonomic Nervous System (ANS) Balance via LF/HF Ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Pressure Pain Threshold (PPT) | 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 |
Countries
Italy
Contacts
CONTACTAntonello Lovato, MD
Outcome results
None listed