Pain SyndromeNCT05108103
Determination of Longus Colli Muscle Thickness by Ultrasonography
An observational study of Pain Syndrome and Pain, Intractable, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Syndrome, Pain, Intractable, Complex Regional Pain Syndromes
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Jun 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age between 18 - 65 years,
- Giving informed consent for examination, ultrasonographic evaluation and study participation
Who cannot join
- Having a chronic neck pain for more than 6 months,
- Having any neurological or musculoskeletal conditions that may affect the anatomy of cervical region (cervical disc herniation, torticollis, severe scoliosis, vertebral malformation, spinal stenosis, myopathies, etc.)
- Having a history of surgery or radiation therapy in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Far Should The Needle Be Withdrawn for Stellate Ganglion Block: Determination of Longus Colli Muscle Thickness by Ultrasonography
This study aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks
Read the detailed description
Stellate ganglion block is an interventional pain management procedure that is often performed for diagnostic and therapeutic purposes. It has long been performed with the guidance of fluoroscopy, and despite the increasing use of ultrasonography in recent years, fluoroscopy is still the gold standard method.
In traditional fluoroscopic method, the needle is directed to the transverse process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.
The ideal placement of the needle should be anterolateral to the longus colli muscle and deep to the prevertebral fascia. Further placement may cause intramuscular spread and superficial placement may cause injection in the carotid sheath or vascular structures. These are the most important reasons for clinical ineffectiveness. How far should the needle be withdrawn? Data is inconsistent in the literature.
The primary aim of this study is to determine the distance from transverse process to longus colli muscles anterior border and from transverse process to carotid sheath's posterior border. Secondary aim is to investigate the relationship between longus colli muscle thickness and age, gender, height, weight, BMI and neck circumference.
- Keywords
- Stellate Ganglion, Longus Colli Muscle, Ultrasound
- Medical subject headings
- Somatoform Disorders, Pain, Intractable, Complex Regional Pain Syndromes, Hyperhidrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters)
Distance between corpus and longus colli muscle's anterior border on C6 level will be evaluated with ultrasonography.
Measured: 0 minutes
Secondary outcomes (5)
Distance between corpus and longus colli muscle's anterior border on C7 level (millimeters)
Distance between corpus and longus colli muscle's anterior border on C7 level will be evaluated with ultrasonography.
Measured: 0 minutes
Maximum anteroposterior width of longus colli muscle on C6 level (millimeters)
Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.
Measured: 0 minutes
Maximum anteroposterior width of longus colli muscle on C7 level (millimeters)
Maximum anteroposterior width of longus colli muscle on C6 level will be evaluated with ultrasonography.
Measured: 0 minutes
Distance between esophagus and estimated needle plane (millimeters)
Distance between esophagus and estimated needle plane will be evaluated with ultrasonography.
Measured: 0 minutes
Neck circumference (centimeters)
Neck circumference
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Mar 2021
- Primary completion1 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Cetingok, Istanbul University
- Investigators
- Halil Çetingök, Ass. Prof., Principal investigator, Istanbul University Istanbul Faculty of Medicine, Department of Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108103
- Sponsor's protocol ID
- 2021/182
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2021
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ates Y, Asik I, Ozgencil E, Acar HI, Yagmurlu B, Tekdemir I. Evaluation of the longus colli muscle in relation to stellate ganglion block. Reg Anesth Pain Med. 2009 May-Jun;34(3):219-23. doi: 10.1097/AAP.0b013e3181a32a02.
PubMed 19436184Narouze 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 24760493
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Far Should The Needle Be Withdrawn for Stellate Ganglion Block: Determination of Longus Colli Muscle Thickness by Ultrasonography
- ClinicalTrials.gov ID
- NCT05108103
- Acronym / sponsor ID
- 2021/182
- Keywords
- Stellate Ganglion, Longus Colli Muscle, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 4 Nov 2021 (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 aims to assess the longus colli muscle thickness by ultrasonography in order to guide stellate ganglion blocks
Detailed description
Stellate ganglion block is an interventional pain management procedure that is often performed for diagnostic and therapeutic purposes. It has long been performed with the guidance of fluoroscopy, and despite the increasing use of ultrasonography in recent years, fluoroscopy is still the gold standard method.
In traditional fluoroscopic method, the needle is directed to the transverse process of the C6 vertebra, after touching the anterior tubercle (Chassaignac's tubercule) the needle is slightly withdrawn and following a negative aspiration, injection is performed.
The ideal placement of the needle should be anterolateral to the longus colli muscle and deep to the prevertebral fascia. Further placement may cause intramuscular spread and superficial placement may cause injection in the carotid sheath or vascular structures. These are the most important reasons for clinical ineffectiveness. How far should the needle be withdrawn? Data is inconsistent in the literature.
The primary aim of this study is to determine the distance from transverse process to longus colli muscles anterior border and from transverse process to carotid sheath's posterior border. Secondary aim is to investigate the relationship between longus colli muscle thickness and age, gender, height, weight, BMI and neck circumference.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Age between 18 - 65 years,
- Giving informed consent for examination, ultrasonographic evaluation and study participation
Key exclusion criteria (3 listed)
- Having a chronic neck pain for more than 6 months,
- Having any neurological or musculoskeletal conditions that may affect the anatomy of cervical region (cervical disc herniation, torticollis, severe scoliosis, vertebral malformation, spinal stenosis, myopathies, etc.)
- Having a history of surgery or radiation therapy in the cervical region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters)
Time frame: 0 minutes
Distance between corpus and longus colli muscle's anterior border on C6 level will be evaluated with ultrasonography.
5 secondary outcomes
Distance between corpus and longus colli muscle's anterior border on C7 level (millimeters)
Time frame: 0 minutes
Maximum anteroposterior width of longus colli muscle on C6 level (millimeters)
Time frame: 0 minutes
Maximum anteroposterior width of longus colli muscle on C7 level (millimeters)
Time frame: 0 minutes
Distance between esophagus and estimated needle plane (millimeters)
Time frame: 0 minutes
Neck circumference (centimeters)
Time frame: 0 minutes
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 3 Oct 2022.
- Background: PubMed 19436184Ates Y, Asik I, Ozgencil E, Acar HI, Yagmurlu B, Tekdemir I. Evaluation of the longus colli muscle in relation to stellate ganglion block. Reg Anesth Pain Med. 2009 May-Jun;34(3):219-23. doi: 10.1097/AAP.0b013e3181a32a02.
- Background: 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.
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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.
Halil Çetingök, Ass. Prof. principal investigator
Istanbul University Istanbul Faculty of Medicine, Department of Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Syndrome and Pain, Intractable, run by Istanbul University 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 2 inclusion and 3 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 3 Oct 2022. 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?
Distance between corpus and longus colli muscle's anterior border on C6 level (millimeters) (time frame: 0 minutes). 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 NCT05108103, which also lists 2 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 3 Oct 2022.