Fibromyalgia
Conditions
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.
Interventions
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.
OTHERNormal 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
Sanliurfa Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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."
Intervention model description
Participants were randomized 1:1 to receive either ultrasound-guided SGB or a sham control procedure.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in FIQR Total Score at 1 Month | Baseline to 1 month | Change in FIQR total score from baseline to 1 month (3 weeks after the second injection). |
| Change in Numerical Rating Scale (NRS) Pain Score | Baseline, 1 week, and 1 month | 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. |
| FIQR Responder Rates (≥30% and ≥50% Improvement) | 1 week and 1 month | Percentage of patients achieving at least 30% and at least 50% reduction in FIQR total score from baseline. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORyagmur Dadakci
Sanliurfa Education and Research Hospital
Outcome results
None listed