Efficacy Ultrasound-guided Genicular Nerve Radiofrequency Treatment
ConditionGonarthrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYunus Burak Bayır
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being a male/female >18
K-L stage 3-4 gonarthrosis patients with anterior knee pain and positive patellofemoral pain tests after physical examination and imaging evaluation
Those whose symptoms persist for >3 months
Participating in the study voluntarily
Disqualifiers
Pregnancy
History of previous knee surgery
Having received physical therapy in the knee area in the last 3 months
Having previously undergone RF treatment or having had any therapeutic injection such as steroids or hyaluronic acid within 3 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Genicular nerve pulse radiofrequency ablation 3
Procedure/SurgeryUltrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves
Genicular nerve pulse radiofrequency ablation 4
Procedure/SurgeryUltrasound-guided genicular nerve radiofrequency therapy targets only the traditional 3 genicular nerves and the intermedius genicular nerve in addition to the traditional genicular nerves.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: 3 nerves protocolActive comparator 1 intervention
Group B: 4 nerves protocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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 procedureSecondary outcomes
1
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.2
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yunus Burak Bayır
Lead sponsor
Ankara Etlik City Hospital
Sponsor institution
Source ClinicalTrials.gov
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