- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05073887
A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets
April 15, 2022 updated by: Selin Guven Kose, Diskapi Teaching and Research Hospital
A Comparison of Ultrasound Guided Genicular Nerve Blockade Using Current Versus Revised Anatomical Targets in Chronic Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial
comparison of effectiveness of ultrasound guided genicular nerve blockades and radio frequency stimulation
Study Overview
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06110
- Diskapi Yildirim Beyazit Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Coagulation disorders
- Rheumatoid disorders
- Infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 3 nerve
3 genicular nerve blockade and radio frequency ablation
|
blockade and radio frequency stimulation of genicular nerves
Other Names:
|
|
ACTIVE_COMPARATOR: 5 nerve
3 genicular nerve blockade and radio frequency ablation 2 genicular nerve blockade and pulse radio frequency
|
blockade and radio frequency stimulation of genicular nerves
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Rating Scale
Time Frame: Post injection sixth month
|
Pain will be evaluated with a Numerical Rating Scale (NRS) score of 0-10 (0= no pain and 10= worst imaginable pain)
|
Post injection sixth month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 10, 2021
Primary Completion (ACTUAL)
December 10, 2021
Study Completion (ACTUAL)
December 20, 2021
Study Registration Dates
First Submitted
September 29, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (ACTUAL)
October 12, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 15, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 106/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.