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

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.

Conditions

• Osteoarthritis, Knee
• Pain, Chronic
• Analgesia

Interventions

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.

Sponsors & Collaborators

• SINPAIN LTDA

  collaborator UNKNOWN

• Universidade Federal de Alfenas

  lead OTHER

Principal Investigators

• Rafaela F Rodrigues, Ph.D · Universidade Federal de Alfenas

• Carlos Marcelo de Barros, MD, FIPP · Sinpain Ltda; Universidade Federal de Alfenas

• Ranielly A Andrade, MD · Santa Casa de Alfenas

• Lúcio César H Silva, MD,FIPP,CIPS · SINPAIN LTDA

• Charles A de Oliveira, MD,FIPP · SINPAIN LTDA

• Paulo Renato B da Fonseca, MD,FIPP,MBA · SINPAIN LTDA

• Fabrício D Assis, MD,FIPP · SINPAIN LTDA

• Tiago S Freitas, MD,Ph.D,FIPP · SINPAIN LTDA

• Vanessa BB Marques, Ph.D · Universidade Federal de Alfenas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-05-31

Completion

2024-07-31

Countries

• Brazil

Study Locations