Stellate Ganglion BlockNCT07129811
Stellate Ganglion Block in Complex Regional Pain Syndrome
A study testing Stellate Ganglion Block in people with Stellate Ganglion Block, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer male and female patients aged 18-75
- Diagnosed with Complex Regional Pain Syndrome according to the IASP 2012 Diagnostic Criteria
- Patient's pain level must be VAS >4
Who cannot join
- Presence of existing neurological diseases other than rheumatic diseases and stroke
- General impairment
- Conditions that would constitute a contraindication to application, such as an open wound or sensory deficit in the application area
- Presence of active infection
- Presence of malignancy
- Cognitive dysfunction (mini mental test result <23)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya
Hüma BÖLÜK ŞENLİKCİ Assoc Prof, +905370630777, humaboluk@gmail.com
About this study
Official title: The Effect of Ultrasound-Guided Stellate Ganglion Block on Pain, Functionality, and Quality of Life in Type 1 Complex Regional Pain Syndrome in Stroke Patients
The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome.
Read the detailed description
Post-stroke complex regional pain syndrome (CRPS) is relatively common in hemiplegic upper extremity. Complex regional Pain Syndrome Type 1 is often seen without any nerve damage especially post-stroke. This musculoskeletal disorder usually effects motor improvement, quality of life and Daily living activities. Besides Presence of CRPS is thought to be challenging on the way of rehabilitation process. However, disproportionate sympthatic nervous system activation, disinhibition of the descenden neuronal pathways are the mechanisms thought to be taken place in the etiopathogenesis of CRPS, it still remains unclear. Pharmacological agents, Physical Therapy techniques, exercise and injections are used to treat CRPS. Therefore post-stroke patients have co-morbidities and multi-drug usage, it should be take into account to treat them with physical therapy agents and interventional procedures. Stellat ganglion blockade is an interventional technique that is used to break the vicious circle of symphatetic activation of upper extremity in CRPS. However to the best of our knowledge there are not any study that evaluates the effect of stellat ganglion Blockade on CPRS combining conventional physical therapy. Total of 32 patients with post-stroke CPRS are going to be participated in the study. Patients are going to be divided into two groups. Group 1 is going to receive both onventional physical therapy, exercise (10 sessions) and stellat ganglion blockade and Group 2 is going to receive just conventional physical therapy program and exercise therapy (10 sessions). Participants are going to evaluate before treatment, 2 weeks and 12 weeks after the end of the therapy sessions. Visual analog scale (VAS), Brunnstroom stages of stroke recovery (BSSR), Fugl-meyer (FMUE) and Stroke spesific quality of life (SSQoL) are used to evaluate pain, functionality and quality of life.
- Conditions
- Stellate Ganglion Block
- Being tested
- Stellate Ganglion Block
- Keywords
- Stroke, chronic pain, Complex regional pain syndrome
- Medical subject headings
- Stroke, Chronic Pain, Complex Regional Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
The stellate ganglion is located in front of the anterior tubercle of the C6 vertebra. An ultrasound-guided intervention will be performed from the affected side and 2 cc of 1% lidocaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Stellat Group | Active comparator | In group 1, stellate ganglion blockade will be applied in addition to conventional physical therapy. Receives: Procedure: Stellate Ganglion Block |
| Only Physical Therapy Group | No intervention | Group 2 will receive only conventional physical therapy and exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Ten-cm VAS was used as a self-report measure for lower back pain intensity. Self reported pain measurement score is between 0-10 and higher scores indicates higher pain severity.
Measured: Before treatment, 2 weeks and 12 weeks after the end of sessions
Secondary outcomes (3)
Brunnstroom stages of stroke recovery (BSSR)
The BSSR is used to evaluate the motor development of the hemiplegic upper extremity, lower extremity and hand in stroke patients using a staging system from 1 (flask) to 6 (normal motor function).
Measured: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Fugl-Meyer Upper Extremity (FMUE) Scale
The FMUE scale is a stroke- specific, performance-based measure of sensory motor impairment consisting of 33 items, each scored on a scale of 0 to 2. Higher scores signify a lower level of impairment.
Measured: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Stroke Specific Quality of Life scale (SS-QOL).
The SS-QOL is a questionnaire used to evaluate independence in ADL in patients with stroke, social role within the family and community and quality of life (QOL). It consists of 49 questions scored between one and five giving a total score between 49 and 245. Higher scores indicate better QOL.
Measured: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher KALIÇ, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129811
- Sponsor's protocol ID
- TABED 1-24-804
- Other IDs
- Ankara Bilkent City Hospital
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Its going to be shared after the end of study
Publications
Yoo SD, Jung SS, Kim HS, Yun DH, Kim DH, Chon J, Hong DW. Efficacy of ultrasonography guided stellate ganglion blockade in the stroke patients with complex regional pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):633-9. doi: 10.5535/arm.2012.36.5.633. Epub 2012 Oct 31.
PubMed 23185727Narouze S. Ultrasound-guided stellate ganglion block: safety and efficacy. Curr Pain Headache Rep. 2014 Jun;18(6):424. doi: 10.1007/s11916-014-0424-5.
PubMed 24760493Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.
PubMed 35687369Altas EU, Onat SS, Konak HE, Polat CS. Post-stroke complex regional pain syndrome and related factors: Experiences from a tertiary rehabilitation center. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):104995. doi: 10.1016/j.jstrokecerebrovasdis.2020.104995. Epub 2020 Jul 3.
PubMed 32807418
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-Guided Stellate Ganglion Block on Pain, Functionality, and Quality of Life in Type 1 Complex Regional Pain Syndrome in Stroke Patients
- ClinicalTrials.gov ID
- NCT07129811
- Acronym / sponsor ID
- TABED 1-24-804
- Conditions
- Stellate Ganglion Block
- Keywords
- Stroke, chronic pain, Complex regional pain syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 19 Aug 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.
The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome.
Detailed description
Post-stroke complex regional pain syndrome (CRPS) is relatively common in hemiplegic upper extremity. Complex regional Pain Syndrome Type 1 is often seen without any nerve damage especially post-stroke. This musculoskeletal disorder usually effects motor improvement, quality of life and Daily living activities. Besides Presence of CRPS is thought to be challenging on the way of rehabilitation process. However, disproportionate sympthatic nervous system activation, disinhibition of the descenden neuronal pathways are the mechanisms thought to be taken place in the etiopathogenesis of CRPS, it still remains unclear. Pharmacological agents, Physical Therapy techniques, exercise and injections are used to treat CRPS. Therefore post-stroke patients have co-morbidities and multi-drug usage, it should be take into account to treat them with physical therapy agents and interventional procedures. Stellat ganglion blockade is an interventional technique that is used to break the vicious circle of symphatetic activation of upper extremity in CRPS. However to the best of our knowledge there are not any study that evaluates the effect of stellat ganglion Blockade on CPRS combining conventional physical therapy. Total of 32 patients with post-stroke CPRS are going to be participated in the study. Patients are going to be divided into two groups. Group 1 is going to receive both onventional physical therapy, exercise (10 sessions) and stellat ganglion blockade and Group 2 is going to receive just conventional physical therapy program and exercise therapy (10 sessions). Participants are going to evaluate before treatment, 2 weeks and 12 weeks after the end of the therapy sessions. Visual analog scale (VAS), Brunnstroom stages of stroke recovery (BSSR), Fugl-meyer (FMUE) and Stroke spesific quality of life (SSQoL) are used to evaluate pain, functionality and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellat Group | Active comparator | Procedure: Stellate Ganglion BlockIn group 1, stellate ganglion blockade will be applied in addition to conventional physical therapy. |
| Only Physical Therapy Group | No intervention | –Group 2 will receive only conventional physical therapy and exercise therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer male and female patients aged 18-75
- Diagnosed with Complex Regional Pain Syndrome according to the IASP 2012 Diagnostic Criteria
- Patient's pain level must be VAS >4
Key exclusion criteria (6 listed)
- Presence of existing neurological diseases other than rheumatic diseases and stroke
- General impairment
- Conditions that would constitute a contraindication to application, such as an open wound or sensory deficit in the application area
- Presence of active infection
- Presence 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 |
|---|---|---|
| Stellate Ganglion BlockThe stellate ganglion is located in front of the anterior tubercle of the C6 vertebra. An ultrasound-guided intervention will be performed from the affected side and 2 cc of 1% lidocaine will be injected. | Procedure or surgery | Stellat Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Before treatment, 2 weeks and 12 weeks after the end of sessions
Ten-cm VAS was used as a self-report measure for lower back pain intensity. Self reported pain measurement score is between 0-10 and higher scores indicates higher pain severity.
3 secondary outcomes
Brunnstroom stages of stroke recovery (BSSR)
Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Fugl-Meyer Upper Extremity (FMUE) Scale
Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Stroke Specific Quality of Life scale (SS-QOL).
Time frame: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 23185727Yoo SD, Jung SS, Kim HS, Yun DH, Kim DH, Chon J, Hong DW. Efficacy of ultrasonography guided stellate ganglion blockade in the stroke patients with complex regional pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):633-9. doi: 10.5535/arm.2012.36.5.633. Epub 2012 Oct 31.
- Results publication: PubMed 24760493Narouze S. Ultrasound-guided stellate ganglion block: safety and efficacy. Curr Pain Headache Rep. 2014 Jun;18(6):424. doi: 10.1007/s11916-014-0424-5.
- Results publication: PubMed 35687369Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.
- Results publication: PubMed 32807418Altas EU, Onat SS, Konak HE, Polat CS. Post-stroke complex regional pain syndrome and related factors: Experiences from a tertiary rehabilitation center. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):104995. doi: 10.1016/j.jstrokecerebrovasdis.2020.104995. Epub 2020 Jul 3.
- Individual participant dataSharing planned: Undecided. Its going to be shared after the end of study
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block in people with Stellate Ganglion Block, 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher KALIÇ MD (+905393628565, seherkalic@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Before treatment, 2 weeks and 12 weeks after the end of sessions). 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 NCT07129811, which also lists 4 linked publications.
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 5 Sep 2025.