NCT05363241

Management of Knee Pain by Cooled Radiofrequency in Classical Anatomical Targets and Revised Targets

Comparison of Genicular Nerve Denervation by Cooled Radiofrequency Using Classical and Revised Anatomical Targets for Pain Management of Osteoarthritis of the Knee Osteoarthritis: Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidade Federal de Alfenas · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Osteoarthritis (OA) is a chronic and progressive disease that results from characteristic pathological changes in the tissues of the entire joint, resulting in failure in the component parts. OA is one of the most common causes of disability in adults due to pain and altered joint function, impacting patients' quality of life. Treatment is based on decreasing pain and improving function, involving non-pharmacological, pharmacological, and surgical management. First-line treatment involves non-pharmacological and pharmacological measures. When OA is very advanced, total joint replacement surgery is recommended. However, for patients refractory to conservative treatment and unwilling or unable to undergo arthroplasty, few options remain. Recently, several studies involving minimally invasive procedures are being recommended. Among them is the cooled radiofrequency technique, causing neurotomy by thermal activity, thus reducing the patient's perception of pain. The classical therapeutic target for this technique are the genicular nerves of the knee. However, more recent studies have shown that these classical targets do not provide complete pain relief and have suggested new therapeutic targets, comprising besides the genicular nerves, the recurrent peroneal nerve and the infra-patellar branch of the saphenous nerve. In order to validate these revised targets, new studies need to be done. Therefore, the aim of the present study is to evaluate the efficacy of the cooled radiofrequency procedure using classical and revised targets, and to compare pain intensity, knee function, quality of life, analgesic consumption and adverse effects of both techniques. Key words: Osteoarthritis of the knee. Sensory nerve denervation. Classical targets. Revised targets.

Detailed description

The present clinical study will be prospective, randomized and double-blind (the principal investigator and the patients will be blinded; the interventional physicians will not be blinded). Patients (n=60) from the Unified Health System of Brazil (SUS), seen at the Singular Alfenas Clinic, selected by the medical team, who meet all inclusion requirements, will be considered for this study; those who agree will sign the informed consent form. After being selected, patients will undergo a test block on the genicular nerves and those who have an improvement of at least 50% will be eligible for the cooled radiofrequency procedure (CRF). Patients will be randomly divided into 3 groups (n=20 patients/group) by sort, made by an external researcher: a) conservative group (CG): patients will receive standard pharmacological treatment (oral analgesics, intra-articular injection with corticosteroids) and physiotherapy for 6 months, and after that period, the performance of the cooled radiofrequency procedure will be guaranteed, with medical indication; b) group cooled radiofrequency with classical targets (CRF-CT): patients will undergo the CRF procedure, using the classical therapeutic targets (medial superior genicular nerve, lateral superior genicular nerve, medial inferior genicular nerve and infra-patellar branch of the saphenous nerve). In order that patients do not know in which group of the study they are included, the probe will be placed on the aforementioned genicular nerves as well as on the recurrent peroneal nerve and the the recurrent fibular nerve and the infra-patellar branch of the saphenous nerve, but will not receive radiofrequency in the recurrent fibular nerve nor in the infra-patellar branch of the saphenous nerve, receiving radiofrequency only in the genicular nerves; c) group cooled radiofrequency with revised targets (CRF-RT): patients will undergo the CRF procedure using the revised therapeutic targets (medial superior genicular nerve, lateral superior genicular nerve; medial inferior genicular nerve, fibular recurrent nerve and infra-patellar branch of the saphenous nerve). In order for patients not to know in which group of the study they are included, the probe will be placed on all the aforementioned nerves and they will receive radiofrequency in all of them. Data will be obtained through the application of questionnaires, for the evaluation of the participants, regarding pain intensity, knee function, analgesic consumption, quality of life and occurrence of adverse effects. The questionnaires will be applied before the block test, to evaluate baseline measurement; after the block test, to verify if there was at least 50% improvement; on the day of the CRF, immediately before the procedure, after the CRF procedure: after 1 week, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months. For the conservative group, the questionnaires will be applied following the same times established for the intervention groups. The results will be obtained through appropriate statistical analyses.

Conditions

• Osteoarthritis, Knee
• Pain, Chronic
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	Cooled radiofrequency in classical targets (CRF-CT)	Participant will take Midazolam 2 mg as a sedative, and will be positioned on a fluoroscopy table in a supine posture, with a pillow under the knee allowing the knee in a slightly flexed position. The skin and subcutaneous tissues will be anesthetized with 2 mL of 1% lidocaine under sterile circumstances. Patients will undergo motor block tests, using 45 volts and 2 hertz, prior to the CRF itself, to ensure that no motor structures will be affected. If the motor test is negative, the CRF procedure will follow, using COOLIEF needles guided by fluoroscopy. A cooled technical chamber will be used, at a temperature of 60° and application for 150 seconds. The targets will be the genicular nerves superior medial, superior lateral, and inferior medial. The participant will not be able to follow the procedure.
PROCEDURE	Cooled radiofrequency in revised targets (CRF-RT)	Participant will take Midazolam 2 mg as a sedative, and will be positioned on a fluoroscopy table in a supine posture, with a pillow under the knee allowing the knee in a slightly flexed position. The skin and subcutaneous tissues will be anesthetized with 2 mL of 1% lidocaine under sterile circumstances. Patients will undergo motor block tests, using 45 volts and 2 hertz, prior to the CRF itself, to ensure that no motor structures will be affected. If the motor test is negative, the CRF procedure will follow, using COOLIEF needles guided by fluoroscopy. A cooled technical chamber will be used, at a temperature of 60° and application for 150 seconds. The targets will be the genicular nerves superior medial, superior lateral, and inferior medial and recurrent fibular nerves and the infra-patellar branch of the saphenous nerve. The participant will not be able to follow the procedure.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2022-05-05
• Last updated: 2022-05-05