Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia

NCT ID: NCT07343128

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2025-12-25

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stellate Ganglion Block

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.

Group Type: EXPERIMENTAL

Lidocaine and Dexamethasone

Intervention Type: 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.

Sham Control

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.

Group Type: SHAM_COMPARATOR

Normal Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Lidocaine Hydrochloride, Dexamethasone Sodium Phosphate; 0.9% Sodium Chloride, Placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanliurfa Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yağmur Can DADAKÇI

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yagmur Dadakci

Role: PRINCIPAL_INVESTIGATOR

Sanliurfa Education and Research Hospital

Locations

Sanliurfa Education and Research Hospital

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HRU-25-1-30

Identifier Type: -

Identifier Source: org_study_id