- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07112300
- Original Trial
Interscalene and ıntertuberculary Pulsed Radiofrequency for Cervical Radiculopathy
Evaluation of the Efficacy of Ultrasound-guided Cervical Root Pulsed Radiofrequency Treatment at the Intertubercular and Interscalene Levels in the Treatment of Cervical Radicular Pain
This study examines the different application techniques of ultrasound-guided pulsed radiofrequency treatment of cervical spinal nerves for cervical radicular pain.
Patients with radiologic imaging findings of C5-C6-C7 disc protrusion or extrusion, with compatible clinical and physical examinations and who have undergone ultrasound-guided spinal cervical nerve radiofrequency treatment in our clinic will be evaluated. Patients' background information will be taken in their files and missing information will be completed by phone call. Pain scores at 3 and 6 months after the procedure will be recorded by scoring from 1 to 10. Patients will not undergo any interventional procedure for research purposes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06170
- Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Radiologically proven extruded/protruded discopathy at C5/C6/C7 levels
- Presence of radicular pain that can be provoked by physical examination
- Consistent with radiologic imaging findings.
Exclusion Criteria:
- No surgical procedures in the cervical region
- Concomitant pregnancy, malignancy, bleeding diathesis
- Presence of rheumatologic diseases associated with concomitant chronic pain syndrome
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Interscalene cervical nerve radiofrequency
The group treated with interscalene pulsed radiofrequency intervention
|
Pulsed radiofrequency treatment is applied to the cervical 5-6-7 nerve roots defined under ultrasound guidance in the intertubercular or interscalene space by approaching the cervical 5-6-7 nerve roots with an inplane technique via a cannula electrode.
|
|
Intertubercular cervical nerve radiofrequency
The group was treated with intertubercular pulsed radiofrequency intervention
|
Pulsed radiofrequency treatment is applied to the cervical 5-6-7 nerve roots defined under ultrasound guidance in the intertubercular or interscalene space by approaching the cervical 5-6-7 nerve roots with an inplane technique via a cannula electrode.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analouge Scale
Time Frame: pretreatment, 3.- 6. months
|
The Visual Analogue Scale (VAS) measures pain intensity.
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line.
|
pretreatment, 3.- 6. months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: pretreatment, 6. months
|
Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain'.
Points summed to a total score.
|
pretreatment, 6. months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Interscalene pRF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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