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

NCT05363241 | Completed DMC

• 1 other identifier: 5.354.533
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knee Osteoarthritis; denervation of sensory nerves of the knee; classical targets; revised targets

Outcome Measures

Primary Outcomes (1)

• Analyze the efficacy of cooled radiofrequency in patients with chronic knee osteoarthritis pain.

  Patients will be evaluated regarding pain intensity (by means of the visual analog scale - VAS), knee function (by means of the WOMAC score translated and validated for the Portuguese language), analgesic consumption (by means of the quantitative analgesic questionnaire - QAQ), the patient's quality of life (using the SF-12 questionnaire translated and validated for the Portuguese language), and the occurrence of adverse effects (using the patients' reports) before the block test, to assess the baseline measurement, and after the block test, to check if there was at least a 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.

  7 months

Secondary Outcomes (1)

• Analyze the lesions of the neurotomized nerves

  2 months

Study Arms (3)

Conservative group (CG)

NO INTERVENTION

The patients will receive standard pharmacological treatment (oral analgesics, intra-articular injection with corticosteroids) and physiotherapy for 6 months, where the end of the study occurs. After this period, the patient is guaranteed to undergo the cooled radiofrequency procedure, with medical indication.

Radiofrequency cooled group with classical targets (CRF-CT)

EXPERIMENTAL

The patients will undergo the CRF procedure using the classical therapeutic targets (medial superior genicular nerve, lateral superior genicular nerve, medial inferior genicular nerve). So that patients do not know in which group of the study they are included, the probe will be placed in the aforementioned genicular nerves and also in the recurrent fibular nerve and in 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. Oral analgesics will be prescribed for the patient to use if necessary.

Procedure: Cooled radiofrequency in classical targets (CRF-CT)

Radiofrequency cooled group with revised targets (CRF-RT)

EXPERIMENTAL

The patients will undergo the CRF procedure using the revised therapeutic targets (medial superior genicular nerve, lateral superior genicular nerve, medial inferior genicular nerve, recurrent fibular nerve and in the infra-patellar branch of the saphenous nerve). So that patients do not know in which group of the study they are included, the probe will be placed in all the aforementioned nerves and will receive radiofrequency in all of them. Oral analgesics will be prescribed for the patient to use if necessary.

Procedure: Cooled radiofrequency in revised targets (CRF-RT)

Interventions

Cooled radiofrequency in classical targets (CRF-CT) PROCEDURE

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.

Radiofrequency cooled group with classical targets (CRF-CT)

Cooled radiofrequency in revised targets (CRF-RT) PROCEDURE

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.

Radiofrequency cooled group with revised targets (CRF-RT)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders aged 40 years or older;
• Patients diagnosed with knee OA through X-rays and MRI (Alhback classification 2 or 3);
• Patients with moderate to severe knee pain (score of 5 or more on the visual analog scale)
• Patients who are literate, can read and write, and have a good understanding of written and verbal language.

You may not qualify if:

• Patients younger than 40 years old, even if diagnosed with knee OA;
• Patients not diagnosed through imaging tests with OA;
• Patients with uncontrolled neurological or psychiatric disease;
• Patients with uncontrolled diabetes;
• Pregnant patients;
• Cancer diagnosed patients;
• Patients with lumbar radiculopathy;
• Patients on continuous anticoagulant therapy;
• Patients who are not literate, can not read and write, and have not a good understanding of written and verbal language.

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead
• SINPAIN LTDA: collaborator

Study Sites (1)

Universidade Federal de Alfenas

Alfenas, Minas Gerais, Brazil

Location

Related Publications (5)

• Carlone AG, Grothaus O, Jacobs C, Duncan ST. Is Cooled Radiofrequency Genicular Nerve Block and Ablation a Viable Option for the Treatment of Knee Osteoarthritis? Arthroplast Today. 2021 Feb 8;7:220-224. doi: 10.1016/j.artd.2020.12.003. eCollection 2021 Feb.

  PMID: 33604437 BACKGROUND

• Fonkoue L, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, De Waroux BLP, Cornu O. Accuracy of fluoroscopic-guided genicular nerve blockade: a need for revisiting anatomical landmarks. Reg Anesth Pain Med. 2019 Aug 26:rapm-2019-100451. doi: 10.1136/rapm-2019-100451. Online ahead of print.

  PMID: 31451628 BACKGROUND

• Fonkoue L, Behets C, Kouassi JK, Coyette M, Detrembleur C, Thienpont E, Cornu O. Distribution of sensory nerves supplying the knee joint capsule and implications for genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat. 2019 Dec;41(12):1461-1471. doi: 10.1007/s00276-019-02291-y. Epub 2019 Jul 23.

  PMID: 31338537 BACKGROUND

• Fonkoue L, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, De Waroux BL, Cornu O. Current versus revised anatomical targets for genicular nerve blockade and radiofrequency ablation: evidence from a cadaveric model. Reg Anesth Pain Med. 2020 Aug;45(8):603-609. doi: 10.1136/rapm-2020-101370. Epub 2020 Jun 18.

  PMID: 32561652 BACKGROUND

• Gonzalez FM. Cooled Radiofrequency Genicular Neurotomy. Tech Vasc Interv Radiol. 2020 Dec;23(4):100706. doi: 10.1016/j.tvir.2020.100706. Epub 2020 Oct 5.

  PMID: 33308582 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Rafaela F Rodrigues, Ph.D

  Universidade Federal de Alfenas

  PRINCIPAL INVESTIGATOR

• Carlos Marcelo de Barros, MD, FIPP

  Sinpain Ltda; Universidade Federal de Alfenas

  STUDY CHAIR

• Ranielly A Andrade, MD

  Santa Casa de Alfenas

  STUDY CHAIR

• Lúcio César H Silva, MD,FIPP,CIPS

  SINPAIN LTDA

  STUDY CHAIR

• Charles A de Oliveira, MD,FIPP

  SINPAIN LTDA

  STUDY CHAIR

• Paulo Renato B da Fonseca, MD,FIPP,MBA

  SINPAIN LTDA

  STUDY CHAIR

• Fabrício D Assis, MD,FIPP

  SINPAIN LTDA

  STUDY CHAIR

• Tiago S Freitas, MD,Ph.D,FIPP

  SINPAIN LTDA

  STUDY CHAIR

• Vanessa BB Marques, Ph.D

  Universidade Federal de Alfenas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 5, 2022
• Study Start: September 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: July 31, 2024
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)