NCT07343128

Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia

Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sanliurfa Education and Research Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, randomized, single-blind, sham-controlled trial conducted at Sanliurfa Education and Research Hospital. Participants: Adults aged 18-65 years diagnosed with fibromyalgia (2016 ACR criteria) who have been receiving a stable dose of duloxetine 60 mg/day for at least 4 weeks but remain symptomatic. Procedures: Participants were randomized 1:1 to either the SGB group or the sham control group. SGB Group: Received ultrasound-guided stellate ganglion block at the C7 level using a mixture of 8 mg dexamethasone and 2 mL of 2% lidocaine (diluted to 7 mL with saline). Sham Group: Received an intramuscular injection of 2 mL normal saline into the sternocleidomastoid muscle under ultrasound guidance. Both groups received two procedures, performed one week apart. All patients continued their fixed-dose duloxetine throughout the study. Assessments: The primary outcome is the change in the FIQR total score from baseline to 1 week. Secondary outcomes include FIQR changes at 1 month, pain intensity (NRS), and responder rates. This is a single-blind study where only the participants were blinded to the intervention.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-25
• Completion: 2025-12-25
• First posted: 2026-01-15
• Last updated: 2026-01-16

Locations

1 site across 1 country: Turkey (Türkiye)