An interventional study of Genicular nerve pulse radiofrequency ablation 3 and Genicular nerve pulse radiofrequency ablation 4 in Gonarthrosis, sponsored by Yunus Burak Bayır. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-02.
Sponsored by Yunus Burak Bayır · Not applicable, Interventional, and Treatment
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.
Our study was designed as a prospective, single-blind randomized controlled study. Patients who applied to our hospital's 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 G*Power 3.1.9.4 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 climbing/descending 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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 72 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Yunus Burak Bayır is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
tradiational the three-nerve genicular RF Group (3RFG),
Procedure: Genicular nerve pulse radiofrequency ablation 3
targeting the intermedius genicular nerve in addition to traditional genicular nerves four-nerve genicular RF Group (4RFG),
Procedure: Genicular nerve pulse radiofrequency ablation 4
Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves
Ultrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves.
Visual Analog Scale (VAS)
The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.
Time frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
WOMAC
WOMAC will be used to determine the functional levels of the patients. The WOMAC consists of 24 items and 3 sub- scales. The pain, stiffness, and physical function subscales were reported as adequate in content and construct validity, as well as responsiveness, in patients with KOA.The total score ranges from 0 to 100. High scores indicate an increase in pain and stiffness, impaired physical function
Time frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure
Kujala Patellofemoral Scoring System
The Kujala patellofemoral score is comprised of 13 questions. These questions inquire whether there is pain during walking up and down stairs, squatting, running, jumping, or prolonged sitting with the knee in flexion; whether there is limping, swelling, or subluxation of the patella; the amount of atrophy in the quadriceps muscle, flexion deficiency, and pain, and whether there is a need for a walking aid. The total score ranges from 0 to 100, the highest indicating the best score
Time frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
Patella Femoral Pain Severity Scale
Patients' pain, such as climbing stairs, squatting down, walking, jogging, running, participating in a sport, sitting with knees in 90° flexion for 20 minutes, standing on their knees, resting/sleeping, and resting after an activity, was evaluated with PPSS. By describing a line drawn in the form of a ruler and numbers from 0 to 10 (0 as "no pain", 10 as "unbearable pain"). The patients were asked to rate their pain according to this scale, considering the last two days. The total score ranges from 0 to 100, the lowest indicating the best score
Time frame: This evaluation will be made and recorded at the baseline, at the 4th and 12th weeks after the procedure.
No study locations are listed for this record.
Plan to share: No
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Yunus Burak Bayır