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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (T0), Week 2 (T2), Week 4 (T4), and Week 8 (T5) |
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Inclusion Criteria:
Confirmed diagnosis of Fibromyalgia by a Rheumatologist according to the 2016 ACR (American College of Rheumatology) criteria.
Exclusion Criteria:
FEMALE
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonello Lovato, MD | Contact | +00390444832740 | lovatoantonello@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Therapy Clinic, Lonigo (VI) | Lonigo | VICENZA | 36045 | Italy |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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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
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| D009422 |
| Nervous System Diseases |