Fibromyalgia SyndromeNCT07641374
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
A study testing The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. in people with Fibromyalgia Syndrome, run by Italian Association for the Research and the Scientific Update at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Pain Therapy Clinic, Lonigo (VI)
Lonigo, VICENZA, 36045
Antonello Lovato, MD, +00390444832740, lovatoantonello@gmail.com
About this study
Official title: Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study
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
Read the 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
- Conditions
- Fibromyalgia Syndrome
- Being tested
- The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point.
- Keywords
- Ear acupuncture, Heart Rate Variability (HRV), pressure pain threshold, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Week 1 (T1), Week 2 (T2), Week 3 (T3), Week 4 (T4), and Follow-up at Week 8 (T5).
Secondary outcomes (1)
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
Measured: Baseline (T0), Week 2 (T2), Week 4 (T4), and Week 8 (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Association for the Research and the Scientific Update
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonello Lovato, Italian Association for the Research and the Scientific Update
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641374
- Sponsor's protocol ID
- AIRAS-FIBRO-2026
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Semi-Permanent Auricular Acupuncture on Autonomic Balance and Pressure Pain Threshold in Patients With Fibromyalgia: A Longitudinal Study
- ClinicalTrials.gov ID
- NCT07641374
- Acronym / sponsor ID
- AIRAS-FIBRO-2026
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Ear acupuncture, Heart Rate Variability (HRV), pressure pain threshold, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Italian Association for the Research and the Scientific UpdateUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia. | Experimental | Device: The 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 |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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 | Device | Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia. |
Primary outcome
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.
1 secondary outcome
Change from baseline in Pressure Pain Threshold (PPT)
Time frame: Baseline (T0), Week 2 (T2), Week 4 (T4), and Week 8 (T5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The needles will be applied to specific auricular points: Point Zero, Shen Men, Thalamus, and Master Cerebral Point. in people with Fibromyalgia Syndrome, run by Italian Association for the Research and the Scientific Update at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonello Lovato, MD (+00390444832740, lovatoantonello@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.