Headache, MigraineSGB-RCMNCT06891118
Stellate Ganglion Blockade for Refractory Chronic Migraine
A study testing Procedure/Surgery: Ultrasound-Guided Stellate Ganglion Block in people with Headache, Migraine and Chronic Migraine Headache, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Stellate Ganglion Block (SGB) is an interventional anesthetic technique used to treat pain conditions affecting the head, face, neck, and upper extremities by temporarily blocking sympathetic nerve output. Ultrasound guidance improves anatomical visualization and facilitates accurate needle placement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache, Migraine, Chronic Migraine Headache
- What is being tested?
- Procedure/Surgery: Ultrasound-Guided Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 30 Dec 2025
- Phase
- Interventional
- 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
- Adults aged 18-65 years.
- Diagnosis of chronic migraine according to ICHD-3 criteria.
- Insufficient clinical response to prior preventive migraine treatment.
- Prior interventional headache treatment performed at least 3 months before enrollment, with insufficient clinical benefit.
- Willingness and ability to participate in the study, comply with follow-up, and undergo the planned interventional treatment.
Who cannot join
- History of a primary headache disorder other than migraine.
- Migraine-related interventional treatment, botulinum toxin A treatment, or nonpharmacological headache treatment (e.g., acupuncture, ozone therapy, or cognitive behavioral therapy) within the previous 3 months.
- Infection at the planned injection site.
- Pregnancy or suspected pregnancy.
- Known allergy to local anesthetic agents.
- History of malignancy or cranial/cervical surgery.
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- Bleeding or coagulation disorder, or current oral anticoagulant therapy.
- Comorbid conditions that could contribute to headache, such as uncontrolled hypertension or intracranial lesions.
- Conditions that could impair adherence to the treatment or follow-up protocol, such as significant psychiatric disease or dementia.
- Unwillingness to undergo the planned interventional treatment or to continue the study protocol.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Ankara Bilkent City Hospital
Ankara, Cankaya, 06800
About this study
Official title: Ultrasound-Guided Stellate Ganglion Block for Refractory Chronic Migraine: A Prospective Evaluation
Stellate Ganglion Block (SGB) is an interventional anesthetic technique used to treat pain conditions affecting the head, face, neck, and upper extremities by temporarily blocking sympathetic nerve output. Ultrasound guidance improves anatomical visualization and facilitates accurate needle placement.
Emerging evidence suggests that repeated ultrasound-guided SGB may be associated with reductions in headache intensity and frequency in patients with migraine and with improvement in migraine-related disability. However, limited data exist regarding its use in highly treatment-resistant chronic migraine, particularly in patients who have not responded adequately to preventive pharmacological therapies and prior interventional treatments.
The primary objective of this study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary objectives include assessing changes in pain intensity, migraine-related disability, analgesic use, patient-reported global improvement, and treatment tolerability.
Read the detailed description
Migraine is a common neurological disorder, and approximately 8% of patients develop chronic migraine (CM), defined as headache occurring on 15 or more days per month for more than three months, with at least 8 days fulfilling migraine criteria. Chronic migraine is associated with substantial disability and reduced quality of life.
In patients who do not respond adequately to preventive pharmacological therapies, interventional procedures such as greater occipital nerve blocks, sphenopalatine ganglion blocks, pulsed radiofrequency procedures, and botulinum toxin injections may be considered. However, a subset of patients continues to experience persistent and disabling symptoms despite these interventions.
The stellate ganglion is formed by the fusion of the inferior cervical and first thoracic sympathetic ganglia and plays a key role in cervical sympathetic outflow. Stellate ganglion block (SGB) involves the injection of local anesthetic around the stellate ganglion to temporarily inhibit sympathetic activity. Ultrasound guidance allows real-time visualization of anatomical structures, reduces the risk of vascular injury, and avoids radiation exposure.
In this study, SGB is performed under sterile conditions with continuous monitoring and real-time ultrasound guidance. A linear ultrasound probe is positioned at the level of the sixth cervical vertebra to identify relevant anatomical structures. A 22-gauge, 90-mm needle is advanced using an in-plane technique, and 5 mL of 1% lidocaine is administered after confirming correct placement. For participants with bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides.
The primary aim of the study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary aims include evaluation of pain intensity, headache-related disability, analgesic use, patient-reported global improvement, and tolerability outcomes.
The original study protocol was approved on 6 March 2024 (TABED 2-24-33) and initially specified follow-up through 3 months. The study was retrospectively registered at ClinicalTrials.gov (NCT06891118); the initial registration was submitted on 6 March 2025 and first posted on 24 March 2025. A formal protocol amendment was submitted on 30 October 2025, while follow-up data collection was ongoing and before statistical analysis, to extend follow-up from 3 to 6 months and to define the final assessment time points as months 1, 3, and 6. The amendment was approved by the institutional ethics committee on 26 November 2025 (TABED 2-25-1653). The ClinicalTrials.gov record was subsequently updated to reflect the approved 6-month follow-up and the primary outcome, defined as change in Monthly Headache Days from baseline to 6 months.
- Conditions
- Headache, Migraine, Chronic Migraine Headache
- Being tested
- Procedure/Surgery: Ultrasound-Guided Stellate Ganglion Block
- Keywords
- Migraine, Stellate Ganglion, Nerve Blockade, ultrasonography guided
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure/Surgery: Ultrasound-Guided Stellate Ganglion BlockProcedure or surgery
Ultrasound-guided SGB was performed under sterile conditions with intravenous access and continuous monitoring. With the patient in the supine position, a linear ultrasound probe was placed transversely at the C6 level to identify the longus colli muscle, prevertebral fascia, carotid artery, internal jugular vein, thyroid gland, and adjacent vascular structures. A 22-gauge, 90-mm needle was advanced using an in-plane lateral-to-medial approach toward the prevertebral fascia anterior to the longus colli muscle. After negative aspiration and confirmation of needle position, 5 mL of 1% lidocaine was administered. For bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides.
| Study group | Role | What they receive |
|---|---|---|
| SGB blockade patients | Experimental | Adults aged 18-65 years with chronic migraine diagnosed according to ICHD-3 criteria, with insufficient clinical response to prior preventive migraine treatment and prior interventional headache treatment. Receives: Procedure: Procedure/Surgery: Ultrasound-Guided Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Monthly Headache Days (MHD)
Change in the number of Monthly Headache Days from baseline to 6 months. A headache day was defined as a calendar day on which headache lasted continuously for at least 4 hours and reached at least moderate intensity, or on which acute medication was used to treat headache regardless of headache duration or intensity. Monthly headache information was collected using patient headache follow-up forms and structured patient-reported information obtained at scheduled follow-up visits.
Measured: Baseline to 6 months
Secondary outcomes (5)
Visual Analog Scale (VAS) pain score
The Visual Analog Scale (VAS) was used to assess headache pain intensity on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants reported both average and peak headache pain intensity at each assessment.
Measured: Baseline, 1 month, 3 months, and 6 months
Number of Days Requiring Analgesic Use
The number of days per month in which participants used analgesic medication for headache relief. Analgesic-use information was collected using patient headache follow-up forms and structured patient-reported information obtained at scheduled follow-up visits.
Measured: Baseline, 1 month, 3 months, and 6 months
The Global Perceived Effect (GPE)
The Global Perceived Effect (GPE) scale is a patient-reported measure assessing overall perceived change compared with baseline. Participants rated their overall treatment response on a 7-point ordinal scale ranging from 1 (very much worsened) to 7 (very much improved). Clinically meaningful improvement was defined as a GPE score ≥6.
Measured: 1 month, 3 months, and 6 months
Headache Impact Test (HIT-6) Score
The Headache Impact Test (HIT-6) is a validated 6-item questionnaire assessing the impact of headache on daily functioning. Total scores range from 36 to 78, with higher scores indicating greater headache-related disability. Changes in HIT-6 scores over time were evaluated.
Measured: Baseline, 1 month, 3 months, and 6 months
Migraine Disability Assessment (MIDAS) Score
The Migraine Disability Assessment (MIDAS) questionnaire evaluates headache-related disability over the preceding three months. Higher scores indicate greater disability. Changes in MIDAS scores over time were assessed.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start6 Mar 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-center, prospective, uncontrolled, single-group interventional study
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şükriye Dadalı, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891118
- Sponsor's protocol ID
- TABED-2-24-33
- Acronym
- SGB-RCM
- Status last verified
- Sep 2026
- First submitted
- 6 Mar 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Stellate Ganglion Block for Refractory Chronic Migraine: A Prospective Evaluation
- ClinicalTrials.gov ID
- NCT06891118
- Acronym / sponsor ID
- SGB-RCM / TABED-2-24-33
- Conditions
- Headache, Migraine, Chronic Migraine Headache
- Keywords
- Migraine, Stellate Ganglion, Nerve Blockade, ultrasonography guided
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 24 Mar 2025 (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.
Stellate Ganglion Block (SGB) is an interventional anesthetic technique used to treat pain conditions affecting the head, face, neck, and upper extremities by temporarily blocking sympathetic nerve output. Ultrasound guidance improves anatomical visualization and facilitates accurate needle placement.
Emerging evidence suggests that repeated ultrasound-guided SGB may be associated with reductions in headache intensity and frequency in patients with migraine and with improvement in migraine-related disability. However, limited data exist regarding its use in highly treatment-resistant chronic migraine, particularly in patients who have not responded adequately to preventive pharmacological therapies and prior interventional treatments.
The primary objective of this study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary objectives include assessing changes in pain intensity, migraine-related disability, analgesic use, patient-reported global improvement, and treatment tolerability.
Detailed description
Migraine is a common neurological disorder, and approximately 8% of patients develop chronic migraine (CM), defined as headache occurring on 15 or more days per month for more than three months, with at least 8 days fulfilling migraine criteria. Chronic migraine is associated with substantial disability and reduced quality of life.
In patients who do not respond adequately to preventive pharmacological therapies, interventional procedures such as greater occipital nerve blocks, sphenopalatine ganglion blocks, pulsed radiofrequency procedures, and botulinum toxin injections may be considered. However, a subset of patients continues to experience persistent and disabling symptoms despite these interventions.
The stellate ganglion is formed by the fusion of the inferior cervical and first thoracic sympathetic ganglia and plays a key role in cervical sympathetic outflow. Stellate ganglion block (SGB) involves the injection of local anesthetic around the stellate ganglion to temporarily inhibit sympathetic activity. Ultrasound guidance allows real-time visualization of anatomical structures, reduces the risk of vascular injury, and avoids radiation exposure.
In this study, SGB is performed under sterile conditions with continuous monitoring and real-time ultrasound guidance. A linear ultrasound probe is positioned at the level of the sixth cervical vertebra to identify relevant anatomical structures. A 22-gauge, 90-mm needle is advanced using an in-plane technique, and 5 mL of 1% lidocaine is administered after confirming correct placement. For participants with bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides.
The primary aim of the study is to evaluate 6-month clinical outcomes following ultrasound-guided SGB in patients with treatment-resistant chronic migraine. Secondary aims include evaluation of pain intensity, headache-related disability, analgesic use, patient-reported global improvement, and tolerability outcomes.
The original study protocol was approved on 6 March 2024 (TABED 2-24-33) and initially specified follow-up through 3 months. The study was retrospectively registered at ClinicalTrials.gov (NCT06891118); the initial registration was submitted on 6 March 2025 and first posted on 24 March 2025. A formal protocol amendment was submitted on 30 October 2025, while follow-up data collection was ongoing and before statistical analysis, to extend follow-up from 3 to 6 months and to define the final assessment time points as months 1, 3, and 6. The amendment was approved by the institutional ethics committee on 26 November 2025 (TABED 2-25-1653). The ClinicalTrials.gov record was subsequently updated to reflect the approved 6-month follow-up and the primary outcome, defined as change in Monthly Headache Days from baseline to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-center, prospective, uncontrolled, single-group interventional study
| Arm | Type | Receives |
|---|---|---|
| SGB blockade patients | Experimental | Procedure: Procedure/Surgery: Ultrasound-Guided Stellate Ganglion BlockAdults aged 18-65 years with chronic migraine diagnosed according to ICHD-3 criteria, with insufficient clinical response to prior preventive migraine treatment and prior interventional headache treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years.
- Diagnosis of chronic migraine according to ICHD-3 criteria.
- Insufficient clinical response to prior preventive migraine treatment.
- Prior interventional headache treatment performed at least 3 months before enrollment, with insufficient clinical benefit.
- Willingness and ability to participate in the study, comply with follow-up, and undergo the planned interventional treatment.
Key exclusion criteria (10 listed)
- History of a primary headache disorder other than migraine.
- Migraine-related interventional treatment, botulinum toxin A treatment, or nonpharmacological headache treatment (e.g., acupuncture, ozone therapy, or cognitive behavioral therapy) within the previous 3 months.
- Infection at the planned injection site.
- Pregnancy or suspected pregnancy.
- Known allergy to local anesthetic agents.
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 |
|---|---|---|
| Procedure/Surgery: Ultrasound-Guided Stellate Ganglion BlockUltrasound-guided SGB was performed under sterile conditions with intravenous access and continuous monitoring. With the patient in the supine position, a linear ultrasound probe was placed transversely at the C6 level to identify the longus colli muscle, prevertebral fascia, carotid artery, internal jugular vein, thyroid gland, and adjacent vascular structures. A 22-gauge, 90-mm needle was advanced using an in-plane lateral-to-medial approach toward the prevertebral fascia anterior to the longus colli muscle. After negative aspiration and confirmation of needle position, 5 mL of 1% lidocaine was administered. For bilateral headache distribution, bilateral blocks were performed sequentially with a minimum 60-minute interval between sides. | Procedure or surgery | SGB blockade patients |
Primary outcome
Change in Monthly Headache Days (MHD)
Time frame: Baseline to 6 months
Change in the number of Monthly Headache Days from baseline to 6 months. A headache day was defined as a calendar day on which headache lasted continuously for at least 4 hours and reached at least moderate intensity, or on which acute medication was used to treat headache regardless of headache duration or intensity. Monthly headache information was collected using patient headache follow-up forms and structured patient-reported information obtained at scheduled follow-up visits.
5 secondary outcomes
Visual Analog Scale (VAS) pain score
Time frame: Baseline, 1 month, 3 months, and 6 months
Number of Days Requiring Analgesic Use
Time frame: Baseline, 1 month, 3 months, and 6 months
The Global Perceived Effect (GPE)
Time frame: 1 month, 3 months, and 6 months
Headache Impact Test (HIT-6) Score
Time frame: Baseline, 1 month, 3 months, and 6 months
Migraine Disability Assessment (MIDAS) Score
Time frame: Baseline, 3 months, and 6 months
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 9 Sep 2026.
- Yu B, Zhang W, Zhao C, Xing Y, Meng L, Luo F. Effectiveness, safety, and predictors of response to ultrasound-guided stellate ganglion blockades for the treatment of patients with chronic migraine: A retrospective and observational study. Pain Pract.2023Link provided by the sponsor.
- Yu B, Hou S, Xing Y, Jia Z, Luo F. Ultrasound-guided stellate ganglion block for the treatment of migraine in elderly patients: A retrospective and observational study. Headache. 2023; 63:763-770. doi:10.1111/head.14537.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Privacy.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure/Surgery: Ultrasound-Guided Stellate Ganglion Block in people with Headache, Migraine and Chronic Migraine Headache, run by Ankara City Hospital Bilkent 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 10 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 9 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Monthly Headache Days (MHD) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.