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Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia

NCT07343128 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-01-16

No results posted yet for this study

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

Interventions

DRUG

Lidocaine and Dexamethasone

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.

OTHER

Normal Saline

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

Sponsors & Collaborators

  • Sanliurfa Education and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • yagmur Dadakci · Sanliurfa Education and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2025-12-25
Completion
2025-12-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343128 on ClinicalTrials.gov