Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia

NCT07343128 | Completed Phase 2

• 1 other identifier: HRU-25-1-30
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score

  The FIQR is a 21-item validated instrument that assesses the overall impact of fibromyalgia on physical function, overall impact, and symptoms. Total score ranges from 0 to 100, with higher scores indicating greater disease impact. Change from baseline to 1 week is the primary endpoint.

  Baseline to 1 week after the first injection

Secondary Outcomes (3)

• Change in FIQR Total Score at 1 Month

  Baseline to 1 month

• Change in Numerical Rating Scale (NRS) Pain Score

  Baseline, 1 week, and 1 month

• FIQR Responder Rates (≥30% and ≥50% Improvement)

  1 week and 1 month

Study Arms (2)

Stellate Ganglion Block

EXPERIMENTAL

Participants in this group received two ultrasound-guided stellate ganglion blocks at the C7 level, performed one week apart. Under real-time ultrasound guidance, a 22-gauge spinal needle was advanced to the stellate ganglion region. Following negative aspiration, a 7 mL mixture containing 8 mg of non-particulate dexamethasone and 2 mL of 2% lidocaine (diluted with normal saline) was injected. Success was clinically confirmed by the development of ipsilateral Horner syndrome.

Drug: Lidocaine and Dexamethasone

Sham Control

SHAM COMPARATOR

Participants in this group underwent the same preparation, positioning, and ultrasound imaging as the intervention group to maintain blinding. They received two sham procedures, performed one week apart. In each procedure, 2 mL of normal saline was injected intramuscularly into the sternocleidomastoid muscle in a region distant from the stellate ganglion. This procedure replicated the needle insertion and ultrasound application without affecting the sympathetic nerves.

Other: Normal Saline

Interventions

Lidocaine and Dexamethasone DRUG

A mixture of 2 mL of 2% lidocaine and 8 mg of non-particulate dexamethasone, diluted with normal saline to a total volume of 7 mL. Administered via ultrasound-guided injection at the C7 level. Two doses in total, with a one-week interval.

Also known as: Lidocaine Hydrochloride, Dexamethasone Sodium Phosphate

Stellate Ganglion Block

Normal Saline OTHER

2 mL of 0.9% normal saline administered via intramuscular injection into the sternocleidomastoid muscle. Two doses in total, with a one-week interval.

Also known as: 0.9% Sodium Chloride, Placebo

Sham Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness to continue the fixed dose of duloxetine throughout the study.
• Aged between 18 and 65 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanliurfa Education and Research Hospital: lead

Study Sites (1)

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, 63290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Lidocaine; Dexamethasone; dexamethasone 21-phosphate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• yagmur Dadakci

  Sanliurfa Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: "Single-blind. Participants were blinded to treatment assignment. The investigator performing the procedures and the outcome assessors were aware of the group allocation."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized 1:1 to receive either ultrasound-guided SGB or a sham control procedure.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: June 1, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)