CompletedPhase 2/3

Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia

Turkey (Türkiye)68 participantsStarted 2025-06-01

Plain-language summary

This study evaluates the efficacy and safety of ultrasound-guided stellate ganglion block (SGB) as an adjunctive treatment for patients with treatment-resistant fibromyalgia. Patients who continue to experience significant symptoms despite stable duloxetine therapy (60 mg/day) were randomized to receive either ultrasound-guided SGB or a sham control procedure. The study aims to determine if SGB can provide clinically meaningful improvements in fibromyalgia impact and pain intensity compared to a sham injection.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Fibromyalgia Syndrome (FMS) according to the 2016 American College of Rheumatology criteria. * Followed for at least 1 year with insufficient benefit from previous pharmacological and/or non-pharmacological treatments. * Receiving a stable dose of duloxetine 60 mg once daily for at least 4 weeks prior to inclusion. * Willingness to continue the fixed dose of duloxetine throughout the study. * Aged between 18 and 65 years. Exclusion Criteria: * Non-pharmacological treatments within the previous 6 months (e.g., acupuncture, ozone therapy, cognitive behavioral therapy). * Local infection at the injection site. * Pregnancy or suspected pregnancy. * Known allergy to local anesthetics. * History of malignancy. * Bleeding or coagulation disorders or use of oral anticoagulants. * Uncontrolled hypertension, diabetes mellitus, asthma, chronic obstructive pulmonary disease, or heart failure. * Psychiatric or cognitive disorders that could interfere with treatment compliance (e.g., severe psychiatric illness, dementia). * Refusal of interventional treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score

Timeframe: Baseline to 1 week after the first injection

Trial details

NCT IDNCT07343128

SponsorSanliurfa Education and Research Hospital

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-12-25

View on ClinicalTrials.gov More Fibromyalgia trials