Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

Study Overview
=================
Brief Summary
-----------------
Radiofrequency application is a treatment method that temporarily prevents the transmission of pain in the nerve where the application is made through the heat emitted by radio waves.Partial inhibition of the functions of the nerves carrying the joint pain sensation with this method is the basis of the treatment.The intermedius genicular nerve carries the sensation of subpatellar pain due to chondromalacia.In this study,investigators aim is to investigate the effect of radiofrequency neurotomy applied to the intermedius genicular nerve, which receives the sensation of the patella, on pain and knee function in patients with a diagnosis of chondromalacia patella who have anterior knee pain that does not resolve despite conservative treatment, under the guidance of ultrasonography.

Detailed Description
-----------------
The study was designed as prospective, randomized, controlled trial. 46 people who met the inclusion criteria were randomized into two groups of 23 people. The first group will be designated as Nerve blockage group and nerve blocking program will be applied to these patients. Patients in the second group will be designated as the Radiofrequency group and radiofrequency ablation after the blockade program will be applied in accordance with the radiofrequency ablation protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala's Patellofemoral Scoring System (KPSS).

Official Title
-----------------
The Efficiency of Radiofrequency Ablation Therapy Applied to the Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

Conditions
-----------------
Chondromalacia Patellae

Intervention / Treatment
-----------------
* Procedure: radiofrequency
* Procedure: control
* Drug: 2% lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female aged >18 years Diagnosis of chondromalacia patella after physical examination and MR imaging Those whose symptoms persist for >3 months Participating in the study voluntarily Exclusion Criteria: Pregnant patients History of previous knee surgery To have received physical therapy from the knee area in the last 6 months Previous RF treatment or any therapeutic injection of the knee such as steroid, hyaluronic acid within 3 months Those with pain radiating from the waist or hip Patients with neuropathic pain History of tumor, infectious, psychiatric disease, bleeding diathesis History of knee trauma in the last 6 months Those with systemic diseases such as hepatitis, coagulopathy Patients with BMI >40 Finding a leg length difference

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiofrequency group<br>the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve. | Procedure: radiofrequency<br>* the radiofrequency needle will be advanced percutaneously towards the intermedius genicular nerve on the periosteum of the distal femoral shaft region until bone contact is achieved. In addition to imaging the nerve with ultrasound, sensory stimulation at 50 Hz frequency will be applied with a threshold value less than 0.6 V in order to determine its position more accurately. In order to prevent the inactivation of the motor nerves, the relevant nerve will be tested for the absence of fasciculation in the region of the lower extremity compatible with the application with the stimulation with a frequency of 2.0 V and 2 Hz. Before the activation of the Baylis brand radiofrequency generator, an injection of 1 ml of 2% lidocaine will be made, then the radiofrequency electrode will be added to the needle and the temperature level at the tip of the electrode will be increased to 80 degrees for 2 minutes, the procedure will be performed for each genicular nerve.<br>Drug: 2% lidocaine<br>* 2% lidocaine<br>|
| Active Comparator: control group<br>The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine. | Procedure: control<br>* The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.<br>Drug: 2% lidocaine<br>* 2% lidocaine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain Severity of pain was assessed using the standard 10 cm VAS with 0 meant no pain at one end, and 10 meant unbearable pain at the other end initial, 4th week 7th week 24th week pain change | Severity of pain was assessed using the standard 10 cm VAS with 0 meant no pain at one end, and 10 meant unbearable pain at the other end | Change from Baseline , 4th week 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patello Femoral Pain Intensity Scale | Patello Femoral Pain Intensity Scale to evaluate patients' pain in climbing / descending stairs, squatting, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activityStair climbing / descending, crouching, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activity, travel 10 cm as standard 0 no pain at one end, 10 At the other end it was rated as excruciating pain with a total score of 100. | Change from Baseline, 4th week 12th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radiofrequency neurotomy, knee pain, ultrasound