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Selective Cervical Root Block for Chronic Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided selective cervical nerve root block
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neck Pain focused on measuring Sonoanatomy, Cervical nerve root block, Neck pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

healthy volunteers patients with cervical radicular pain

Exclusion Criteria:

Patients who have structural disorders in the neck region and who have undergone neck surgery

-

Sites / Locations

  • Dişkapi Reserch and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Other

Arm Label

healthy volunteers

patients with cervical radicular pain

human cadavers

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 17, 2022
Last Updated
August 28, 2023
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05450926
Brief Title
Selective Cervical Root Block for Chronic Pain
Official Title
Appropriate Sonoanatomical Approach in Ultrasound-guided Selective Cervical Root Block
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Sonoanatomy, Cervical nerve root block, Neck pain

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
No Intervention
Arm Description
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.
Arm Title
patients with cervical radicular pain
Arm Type
Active Comparator
Arm Description
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.
Arm Title
human cadavers
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided selective cervical nerve root block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluating the vascular structures around the needle pathway while approaching the nerve to be applied cervical spinal nerve block with a needle.
Description
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.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
VAS (visual analog scale)
Description
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.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy volunteers patients with cervical radicular pain Exclusion Criteria: Patients who have structural disorders in the neck region and who have undergone neck surgery -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömer Taylan Akkaya
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayhan Cömert
Organizational Affiliation
Ankara University Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Damla Yürük
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dişkapi Reserch and Education Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Selective Cervical Root Block for Chronic Pain

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