- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07447271
Ultrasound Guided Cervical Selective Nerve Root Block Versus Fluoroscopic Guided Cervical Transforaminal Epidural Block
Comparison of the Therapeutic Efficacy and Safety of Ultrasound-guided Cervical Selective Nerve Root Block and Fluoroscopic Guided Cervical Transforaminal Epidural Block in Patients With Cervical Radiculopathy: A Retrospective Study
This study retrospectively analyzed medical records and imaging records (ultrasound images, fluoroscopy-guided images) of US-CSNRB and FL-CTFEB procedures performed at the Yangsan Pusan National University Hospital Pain Clinic outpatient department from May 1, 2019, to April 30, 2024. It compared the therapeutic effects (pain reduction), procedure-related indicators (comparison of contrast agent spread), safety (incidence of complications), and changes in analgesic usage.
The primary outcome of this study is the difference in pain chage (Visual Analogue Scale, VAS) between patients undergoing US-CSNRB and FL-CTFEB. The secondary outcomes are comparison of contrast agent spread and comparison of procedure-related complication rates.
Study Overview
Status
Conditions
Detailed Description
The following information is retrospectively collected and observed for comparison based on the electronic medical records of selected patients.
- Patient characteristics: Age, height, weight, gender, lesion segment (e.g., C6/C7), comorbidities
- Procedure-related indicators:
1) Procedure method (US-CSNRB or FL-CTFEB) 2) Procedure site, procedure level, adverse events during the procedure 3) Contrast agent distribution pattern: Extent of contrast agent spread into the epidural space and into the nerve roots during the procedure 3. Treatment efficacy indicators: VAS (based on arm pain) at the first visit -baseline, the second visit - 1 month after procedure, the third visit - 2 month after procedure, and 4th visit - 3 months post-procedure; treatment success rate (VAS score reduction of 30% or more) 4. Safety indicators: Presence and type of procedure-related complications documented in medical records (e.g., intravascular injection, nerve injury, local anesthetic toxicity symptoms, transient motor paralysis, etc.).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, South Korea, 50612
- Pusan National University Yangsan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult male and female patients aged 18 years or older.
- Patients diagnosed with cervical radiculopathy who underwent US-guided or FL-guided procedures.
- Patients with clearly documented pain scale (VAS) assessments in medical records at the following time points: 1st visit (before the procedure), 2nd visit, 3rd visit, and at least 3 months post-procedure.
- Patients who underwent procedures for lesions in a single or adjacent two segments.
Exclusion Criteria:
- Patients who underwent surgical treatment within one month after the procedure due to progressive neurological deficits.
- Patients with severe systemic diseases (e.g., cancer, severe immunosuppressive disorders) that may affect pain assessment.
- Patients with severe systemic diseases (e.g., cancer, severe immunosuppressive disorders) that may affect pain assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group U
|
A patient presenting to the pain clinic with cervical neck pain and upper extremity radicular pain, whose symptoms did not improve with medication, demonstrated a positive Spurling test on physical examination, and showed cervical radiculopathy at the C3/4 to C7/T1 level on imaging studies (CT or MRI), underwent an ultrasound-guided cervical selective nerve root block
Other Names:
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Active Comparator: group F
|
A patient presenting to the pain clinic with cervical neck pain and upper extremity radicular pain, whose symptoms did not improve with medication, demonstrated a positive Spurling test on physical examination, and showed cervical radiculopathy at the C3/4 to C7/T1 level on imaging studies (CT or MRI), underwent a fluoroscopy-guided cervical transforaminal epidural block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The difference in pain change
Time Frame: baseline, 1 month, 2 month, 3 month
|
the difference in pain change, assessed using the visual analogue scale (VAS), between patients who underwent US-CSNRB and those who underwent FL-CTFEB
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baseline, 1 month, 2 month, 3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The pattern of contrast spread
Time Frame: periprocedural
|
The pattern of contrast spread during the procedure were evaluated, specifically focusing on the extent of contrast dispersion into the epidural space and along the targeted nerve root.
The incidence of contrast spread into the epidural space and the targeted nerve root area was recorded.
|
periprocedural
|
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The incidence of procedure-related complications
Time Frame: Periprocedural
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The incidence of procedure-related complications were assessed by reviewing the medical records for the occurrence and specific types of procedure-related complications, encompassing adverse events such as inadvertent intravascular injection, nerve injury, symptoms of local anesthetic systemic toxicity (LAST), and transient motor weakness.
|
Periprocedural
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US-CSNRB vs FL-CTFEB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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