Evaluation of Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
Comparative Evaluation of the Ultrasound-guided Radiofrequency Neurolysis and Chemical Neurolysis of the Genicular Nerves
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
April 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedJuly 7, 2023
July 1, 2023
1.2 years
April 14, 2022
July 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to 6 months after procedure
Study Arms (2)
Radiofrequency Neurolysis
ACTIVE COMPARATORRadiofrequency Neurolysis of genicular nerves
Chemical Neurolysis
EXPERIMENTALChemical Neurolysis of genicular nerves
Interventions
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Neurolysis of superomedial, superolateral and inferomedial genicular nerves
Eligibility Criteria
You may not qualify if:
- Coagulation disorders
- Rheumatoid disorders
- Infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06110, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
selin guven kose
Diskapi Yildirim Beyazit Education and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 22, 2022
Study Start
April 24, 2022
Primary Completion
June 20, 2023
Study Completion
July 5, 2023
Last Updated
July 7, 2023
Record last verified: 2023-07