FibromyalgiaPhase 2/3NCT07343128
Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia
A Phase 2/3 study testing Lidocaine and Dexamethasone and Normal Saline in people with Fibromyalgia, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Lidocaine and Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 25 Dec 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa, 63290
About this study
Official title: Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial
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.
Read the 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
- Being tested
- Lidocaine and Dexamethasone, Normal Saline
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine and DexamethasoneDrug
Also called Lidocaine Hydrochloride, Dexamethasone Sodium Phosphate
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.
Normal SalineOther
Also called 0.9% Sodium Chloride, Placebo
2 mL of 0.9% normal saline administered via intramuscular injection into the sternocleidomastoid muscle. Two doses in total, with a one-week interval.
| Study group | Role | What they receive |
|---|---|---|
| Stellate Ganglion Block | Experimental | 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. Receives: Drug: Lidocaine and Dexamethasone |
| Sham Control | Sham comparator | 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. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 1 week after the first injection
Secondary outcomes (3)
Change in FIQR Total Score at 1 Month
Change in FIQR total score from baseline to 1 month (3 weeks after the second injection).
Measured: 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.
Measured: 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.
Measured: 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jun 2025
- Primary completion25 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to receive either ultrasound-guided SGB or a sham control procedure.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yağmur Can DADAKÇI, Sanliurfa Education and Research Hospital
- Investigators
- yagmur Dadakci, Principal investigator, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343128
- Sponsor's protocol ID
- HRU-25-1-30
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect participant privacy. De-identified data may be made available from the corresponding author upon reasonable request and with appropriate institutional approvals.
Publications
Dadakci YC. Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial. Pain Res Manag. 2026;2026(1):e4146674. doi: 10.1155/prm/4146674.
PubMed 42530408
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07343128
- Acronym / sponsor ID
- HRU-25-1-30
- Conditions
- Fibromyalgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to receive either ultrasound-guided SGB or a sham control procedure.
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block | Experimental | Drug: Lidocaine and DexamethasoneParticipants 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. |
| Sham Control | Sham comparator | Other: Normal SalineParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine and DexamethasoneAlso: Lidocaine Hydrochloride, Dexamethasone Sodium PhosphateA 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. | Drug | Stellate Ganglion Block |
| Normal SalineAlso: 0.9% Sodium Chloride, Placebo2 mL of 0.9% normal saline administered via intramuscular injection into the sternocleidomastoid muscle. Two doses in total, with a one-week interval. | Other | Sham Control |
Primary outcome
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.
3 secondary outcomes
Change in FIQR Total Score at 1 Month
Time frame: Baseline to 1 month
Change in Numerical Rating Scale (NRS) Pain Score
Time frame: Baseline, 1 week, and 1 month
FIQR Responder Rates (≥30% and ≥50% Improvement)
Time frame: 1 week and 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 42530408Dadakci YC. Ultrasound-Guided Stellate Ganglion Block in Fibromyalgia: A Randomized, Single-Center, Single-Blind, Sham-Controlled Trial. Pain Res Manag. 2026;2026(1):e4146674. doi: 10.1155/prm/4146674.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared to protect participant privacy. De-identified data may be made available from the corresponding author upon reasonable request and with appropriate institutional approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yagmur Dadakci principal investigator
Sanliurfa Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lidocaine and Dexamethasone and Normal Saline in people with Fibromyalgia, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Total Score (time frame: Baseline to 1 week after the first injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.