Intermedius Genicular Nerve in the Treatment of Patients With Chondromalacia Patella

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chondromalacia Patellae
• Intervention / Treatment: Procedure: radiofrequency; Drug: 2% lidocaine; Procedure: control

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).

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Burak MD BAYIR, MD; Phone Number: +903122911511; Email: yunusburakbayir@gmail.com
• Study Contact Backup: Name: Serdar KESİKBURUN, MD; Phone Number: 903122911402; Email: serdarkb@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Recruiting
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
    • Contact: Burak BAYIR, MD; Phone Number: +903122911511; Email: yunusburakbayir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: radiofrequency group; 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; 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.; Drug: 2% lidocaine; 2% lidocaine
Active Comparator: control group; The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.	Drug: 2% lidocaine; 2% lidocaine; Procedure: control; The intermedius genicular nerve will be found under US guidance and the genicular nerve will be blocked by injecting 1 ml of 2% lidocaine.

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kuala Patellofemoral Scoring System	Kuala Patellofemoral Scoring System was used to determine the functional levels of the patients. Participants were evaluated over a minimum of 0 and a maximum of 100 points	Change from Baseline, 4th week 12th week

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Study Director: Serdar Kesikburun, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; Principal Investigator: Burak BAYIR, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; Principal Investigator: Özlem KÖROĞLU, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; Principal Investigator: Esra ÇELİK KARBANCIOĞLU, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): July 15, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): October 27, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: ultrasound; knee pain; radiofrequency neurotomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases; Chondromalacia Patellae; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No