Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Genicular nerve radiofrequency neurolysis
Genicular nerve chemical neurolysis
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
- Coagulation disorders
- Rheumatoid disorders
- Infections
Sites / Locations
- Diskapi Yildirim Beyazit Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiofrequency Neurolysis
Chemical Neurolysis
Arm Description
Radiofrequency Neurolysis of genicular nerves
Chemical Neurolysis of genicular nerves
Outcomes
Primary Outcome Measures
Numerical Rating Scale (NRS)
Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Secondary Outcome Measures
Full Information
NCT ID
NCT05340166
First Posted
April 14, 2022
Last Updated
July 6, 2023
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05340166
Brief Title
Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Official Title
Comparative Evaluation of the Ultrasound-guided Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
July 5, 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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Knee osteoarthritis is one of the most common causes of pain and loss of function in the elderly population and is a source of socioeconomic costs. Selective denervation of the superior medial, superior lateral and inferior medial genicular nerves, which provide the sensory innervation of the knee joint, is an effective treatment method used to relieve pain and improve functional capacity. Radiofrequency neurolysis of genicular nerves (RFN) is accepted as an effective technique for the treatment of knee pain. However, due to higher equipment costs, longer procedure times, and procedure-related pain, alternative treatments are needed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency Neurolysis
Arm Type
Active Comparator
Arm Description
Radiofrequency Neurolysis of genicular nerves
Arm Title
Chemical Neurolysis
Arm Type
Experimental
Arm Description
Chemical Neurolysis of genicular nerves
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve radiofrequency neurolysis
Intervention Description
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Intervention Type
Procedure
Intervention Name(s)
Genicular nerve chemical neurolysis
Intervention Description
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS)
Description
Pain Score Change The 11-point NRS consists of numbers between 0 and 10 where 0 indicates "no pain" and 10 indicates "maximum pain." The patient is instructed to identify one number between 0 and 10, which is best representative of their pain intensity.
Time Frame
Change from baseline to 6 months after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
Coagulation disorders
Rheumatoid disorders
Infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
selin guven kose
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yildirim Beyazit Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
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