Ignite Creation Date:
2024-07-17 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479642
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-11
Brief Title:
Efficacy Ultrasound-guided Genicular Nerve Radiofrequency Treatment
Sponsor:
Yunus Burak Bayır
Organization:
Ankara Etlik City Hospital
Study Overview
Official Title:
Ultrasound-guided Genicular Nerve Radiofrequency TreatmentEficacy of 4-nerve Protocol Versus 3-nerve Protocol
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radiofrequency RF application is a treatment method that temporarily blocks pain transmission in the nerve where the application is made through the heat emitted by radio waves Genicular nerve ablation with RF has recently become a promising treatment option for the treatment of chronic knee pain These methods are based on the principle that interfering with the sensory nerve fibers of a painful structure can relieve pain and restore function Their targets are sensory nerves located on the periosteum before entering the knee joint capsule The knee joint is innervated by a complex nerve network called genicular nerves which are articular branches of many nerves such as the femoral tibial peroneal saphenous and obturator nerves Some of the genicular nerves can be easily localized The intermedius genicular nerve carries the sensation of subpatellar pain The intermedius genicular nerve is located under the vastus intermedius muscle anterior to the distal femoral shaft just above the bony cortex Targeting sensory nerves in addition to standard procedures and improving target identification using ultrasound guidance may increase treatment success The aim of this study is to investigate the effect of ultrasound-guided genicular nerve radiofrequency therapy on pain and knee function by targeting only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves in advanced gonarthrosis patients with prominent anterior knee pain
Detailed Description:
Our study was designed as a prospective single-blind randomized controlled study Patients who applied to our hospitals FTR outpatient clinic and were diagnosed with advanced stage gonarthrosis with anterior knee pain after physical examination and imaging evaluation will be included in our study The sample size was done using GPower 3194 statistical power analysis program for Windows Based on the study conducted by the effectiveness of genicular RF treatment in chronic knee pain in knee osteoarthritis the number of patients who will provide a 20 significant change in the pre-treatment and 3rd month WOMAC total evaluation with a margin of error of 5 Type 1 and 20 Type 2 a study power of 80 and a confidence interval of 95 is determined for each The minimum required number of patients for a group was found to be 30 patients Considering that there may be a 20 loss during the study it was decided to include at least 36 patients for each group Patients who met the inclusion criteria and completed the Informed Volunteer Consent Forum were selected for the first group with the Research Randomizer computer program The patients will be randomized into two groups of 36 people the three-nerve RF Group 3RFG the second group will be the four-nerve RF Group 4RFG The physician performing the evaluation will be blind to which procedure is performed The demographic and clinical characteristics of the patients will be recorded Patients will be evaluated using the Visual Analogue Scale VAS for knee pain assessment as the primary outcome measure and the patients will be evaluated for climbingdescending stairs squatting walking jogging sprinting sports activities sitting with knees 90 flexed for 20 minutes Patella Femoral Pain Severity Scale will be used to evaluate the pain that occurs while kneeling at rest and after an activity and Kujala Patellofemoral Scoring System and WOMAC will be used to determine the functional levels of the patients These evaluations will be made and recorded at the beginning at the 4th and 12th weeks after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None