Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
"Single-blind. Participants were blinded to treatment assignment. The investigator performing the procedures and the outcome assessors were aware of the group allocation."
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score
Time Frame: Baseline to 1 week after the first injection
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.
Secondary Outcomes
- 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)
Investigators
Yağmur Can DADAKÇI
Principal Investigator
Sanliurfa Education and Research Hospital