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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
68
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.
2 mL of 0.9% normal saline administered via intramuscular injection into the sternocleidomastoid muscle. Two doses in total, with a one-week interval.
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa, Turkey (Türkiye)
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.
Time frame: Baseline to 1 week after the first injection
Change in FIQR Total Score at 1 Month
Change in FIQR total score from baseline to 1 month (3 weeks after the second injection).
Time frame: Baseline to 1 month
Change in Numerical Rating Scale (NRS) Pain Score
Pain intensity over the previous week assessed using an 11-point NRS (0 = no pain, 10 = worst pain imaginable). Change from baseline to 1 week and 1 month.
Time frame: Baseline, 1 week, and 1 month
FIQR Responder Rates (≥30% and ≥50% Improvement)
Percentage of patients achieving at least 30% and at least 50% reduction in FIQR total score from baseline.
Time frame: 1 week and 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.