Neck PainNCT05450926
Selective Cervical Root Block for Chronic Pain
A study testing Ultrasound-guided selective cervical nerve root block in people with Neck Pain, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Currently, selective cervical nerve root injections are recommended under the guidance of fluoroscopy, ultrasonography and computed tomography in patients with chronic cervical radicular pain who do not respond to conservative treatments and are not planned for surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Ultrasound-guided selective cervical nerve root block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2022to 1 Jun 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers patients with cervical radicular pain
Who cannot join
- Patients who have structural disorders in the neck region and who have undergone neck surgery
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Appropriate Sonoanatomical Approach in Ultrasound-guided Selective Cervical Root Block
Currently, selective cervical nerve root injections are recommended under the guidance of fluoroscopy, ultrasonography and computed tomography in patients with chronic cervical radicular pain who do not respond to conservative treatments and are not planned for surgery. Various serious complications, mainly vascular, have been reported in the literature. These complications include vertebral artery injury, spinal cord and brain stem infarction. The arteries of the cervical spinal cord are the vertebral, ascending, and deep cervical arteries arising from the aorta.The arteries arising from these main arteries and reaching the intervertebral foramen are called segmental arteries, the arteries reaching the epidural region from the intervertebral foramen and the radicular arteries, and the branches reaching the spinal cord are called the medullary artery. These small arteries supplying the spinal cord lie close to the spinal nerve in the foramen between the anterior and posterior trabercules. Vasospasm or embolism, which occurs as a result of direct needle trauma to these vascular structures around the target nerve or injection of particulate steroids, are the most common causes of complication development.
The aim of our study is to identify the vascular structures around the foramen in selective cervical root injection, which has proven effectiveness in cervical radicular pain, to determine the most reliable method for positioning the needle while reaching the target nerve under US guidance and to prevent possible complications.
Read the detailed description
A total of 50 healthy volunteers and 10 patients with cervical radicular pain, between the ages of 18-70, height above 155 cm and body mass index 25 and below, in the Algology Clinic of the University of Health Sciences Dışkapı Yıldırım Beyazıt Training and Research Hospital will be included in the study. Those who have structural disorders in the neck region and who have undergone neck surgery will not be included in the study. 7 cadavers will be included in the study in Ankara University Faculty of Medicine, Department of Anatomy.
2 Algology specialists from Health Sciences University Dışkapı Yıldırım Beyazıt Training and Research Hospital Algology Clinic and 3 doctors from Ankara University Medical Faculty Anatomy Department will participate in the study. Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. Again, two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries.
Demographic characteristics (age, gender, BMI, body height) of 50 volunteers and 10 patients with cervical radicular pain will be recorded. The pain intensity of 10 patients with cervical radicular pain will be determined and recorded with the VAS (visual analog scale) score before the procedure and at 1,2,3 and 4 weeks after the procedure, by calling the patients for control.
The cadavers will be dissected after being placed in the supine position and bilaterally from C4 to C7. Neurovascular complexes will be defined.
Efforts will be made to determine the most appropriate needle pathway to reach the target cervical nerve.
- Conditions
- Neck Pain
- Being tested
- Ultrasound-guided selective cervical nerve root block
- Keywords
- Sonoanatomy, Cervical nerve root block, Neck pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided selective cervical nerve root blockProcedure or surgery
The volunteer will be placed in the lateral decubitus position with the examined side up and the ultrasonographic examination will be started. Using a high frequency 6-18 MHz linear transducer, scanning in the cephalad and caudal direction until the cervical tubercles are identified in the short axis of the vertebra at the cricoid level, the localization and number of the target nerve root and vascular structures in the foraminal opening between the anterior and posterior tubercles of the transverse process from C4 to C8. will be defined as Unlike healthy volunteers, local anesthetic and steroid injections will be administered to the target nerve.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | No intervention | Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. |
| patients with cervical radicular pain | Active comparator | Two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. Receives: Procedure: Ultrasound-guided selective cervical nerve root block |
| human cadavers | Other | Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries. Receives: Procedure: Ultrasound-guided selective cervical nerve root block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the vascular structures around the needle pathway while approaching the nerve to be applied cervical spinal nerve block with a needle.
Will evaluate the vascular structures around each C5, C6, and C7 nerve root , with Doppler ultrasound imaging. The pain scores of the patients will be evaluated with VAS (visual analog scale) by applying cervical root block under the guidance of Doppler USG to patients with cervical radicular pain.
Measured: 15 days
Secondary outcomes (1)
VAS (visual analog scale)
Pre- and post-procedure pain scores of the patients will be evaluated with VAS (visual analog scale) by applying cervical root block under the guidance of Doppler USG to patients with cervical radicular pain.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start17 Feb 2022
- Primary completion1 Dec 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Ömer Taylan Akkaya, Study director, Diskapi Yildirim Beyazit Education and Research HospitalAyhan Cömert, Study director, Ankara University Faculty of MedicineDamla Yürük, Principal investigator, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450926
- Sponsor's protocol ID
- Selective cervical root block
- Status last verified
- Aug 2023
- First submitted
- 17 Feb 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Sonoanatomical Approach in Ultrasound-guided Selective Cervical Root Block
- ClinicalTrials.gov ID
- NCT05450926
- Acronym / sponsor ID
- Selective cervical root block
- Conditions
- Neck Pain
- Keywords
- Sonoanatomy, Cervical nerve root block, Neck pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 11 Jul 2022 (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.
Currently, selective cervical nerve root injections are recommended under the guidance of fluoroscopy, ultrasonography and computed tomography in patients with chronic cervical radicular pain who do not respond to conservative treatments and are not planned for surgery. Various serious complications, mainly vascular, have been reported in the literature. These complications include vertebral artery injury, spinal cord and brain stem infarction. The arteries of the cervical spinal cord are the vertebral, ascending, and deep cervical arteries arising from the aorta.The arteries arising from these main arteries and reaching the intervertebral foramen are called segmental arteries, the arteries reaching the epidural region from the intervertebral foramen and the radicular arteries, and the branches reaching the spinal cord are called the medullary artery. These small arteries supplying the spinal cord lie close to the spinal nerve in the foramen between the anterior and posterior trabercules. Vasospasm or embolism, which occurs as a result of direct needle trauma to these vascular structures around the target nerve or injection of particulate steroids, are the most common causes of complication development.
The aim of our study is to identify the vascular structures around the foramen in selective cervical root injection, which has proven effectiveness in cervical radicular pain, to determine the most reliable method for positioning the needle while reaching the target nerve under US guidance and to prevent possible complications.
Detailed description
A total of 50 healthy volunteers and 10 patients with cervical radicular pain, between the ages of 18-70, height above 155 cm and body mass index 25 and below, in the Algology Clinic of the University of Health Sciences Dışkapı Yıldırım Beyazıt Training and Research Hospital will be included in the study. Those who have structural disorders in the neck region and who have undergone neck surgery will not be included in the study. 7 cadavers will be included in the study in Ankara University Faculty of Medicine, Department of Anatomy.
2 Algology specialists from Health Sciences University Dışkapı Yıldırım Beyazıt Training and Research Hospital Algology Clinic and 3 doctors from Ankara University Medical Faculty Anatomy Department will participate in the study. Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. Again, two Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. Seven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries.
Demographic characteristics (age, gender, BMI, body height) of 50 volunteers and 10 patients with cervical radicular pain will be recorded. The pain intensity of 10 patients with cervical radicular pain will be determined and recorded with the VAS (visual analog scale) score before the procedure and at 1,2,3 and 4 weeks after the procedure, by calling the patients for control.
The cadavers will be dissected after being placed in the supine position and bilaterally from C4 to C7. Neurovascular complexes will be defined.
Efforts will be made to determine the most appropriate needle pathway to reach the target cervical nerve.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | No intervention | –Two Algology Specialists will record the localization and number of cervical spinal nerve, transverse process cornes and surrounding vascular structures at cervical C4-5-6-7 levels in healthy volunteers by Doppler USG. |
| patients with cervical radicular pain | Active comparator | Procedure: Ultrasound-guided selective cervical nerve root blockTwo Algology Specialists will apply cervical root block to patients with cervical radicular pain guided by Doppler USG, and pain scores of the patients will be evaluated with VAS (visual analog scale) before and after the procedure. |
| human cadavers | Other | Procedure: Ultrasound-guided selective cervical nerve root blockSeven formalin-containing human cadavers will be examined by 3 anatomy doctors at Ankara University Faculty of Medicine, Department of Anatomy to determine the morphology of the spinal nerve, vertebral artery, assending and deep arteries in the cervical foraminal region, as well as the radicular arteries. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers patients with cervical radicular pain
Key exclusion criteria (2 listed)
- Patients who have structural disorders in the neck region and who have undergone neck surgery
- -
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 |
|---|---|---|
| Ultrasound-guided selective cervical nerve root blockThe volunteer will be placed in the lateral decubitus position with the examined side up and the ultrasonographic examination will be started. Using a high frequency 6-18 MHz linear transducer, scanning in the cephalad and caudal direction until the cervical tubercles are identified in the short axis of the vertebra at the cricoid level, the localization and number of the target nerve root and vascular structures in the foraminal opening between the anterior and posterior tubercles of the transverse process from C4 to C8. will be defined as Unlike healthy volunteers, local anesthetic and steroid injections will be administered to the target nerve. | Procedure or surgery | human cadavers, patients with cervical radicular pain |
Primary outcome
Evaluating the vascular structures around the needle pathway while approaching the nerve to be applied cervical spinal nerve block with a needle.
Time frame: 15 days
Will evaluate the vascular structures around each C5, C6, and C7 nerve root , with Doppler ultrasound imaging. The pain scores of the patients will be evaluated with VAS (visual analog scale) by applying cervical root block under the guidance of Doppler USG to patients with cervical radicular pain.
1 secondary outcome
VAS (visual analog scale)
Time frame: 15 days
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 30 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Ömer Taylan Akkaya study director
Diskapi Yildirim Beyazit Education and Research Hospital
Ayhan Cömert study director
Ankara University Faculty of Medicine
Damla Yürük principal investigator
Diskapi Yildirim Beyazit 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 study testing Ultrasound-guided selective cervical nerve root block in people with Neck Pain, run by Diskapi Teaching 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 1 inclusion and 2 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 30 Aug 2023. 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?
Evaluating the vascular structures around the needle pathway while approaching the nerve to be applied cervical spinal nerve block with a needle. (time frame: 15 days). 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 30 Aug 2023.