Osteoarthritis, KneeNCT05363241
Management of Knee Pain by Cooled Radiofrequency in Classical Anatomical Targets and Revised Targets
A study testing Cooled radiofrequency in classical targets (CRF-CT) and Cooled radiofrequency in revised targets (CRF-RT) in people with Osteoarthritis, Knee and Pain, Chronic, run by Universidade Federal de Alfenas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Pain, Chronic, Analgesia
- What is being tested?
- Cooled radiofrequency in classical targets (CRF-CT) and Cooled radiofrequency in revised targets (CRF-RT)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 chronic knee pain for more than 3 months at the time of inclusion;
- 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.
Who cannot join
- Patients younger than 40 years old, even if diagnosed with knee OA;
- Patients not diagnosed through imaging tests with OA;
- Patients who have undergone previous knee surgery in the last 3 months before inclusion;
- Patients who have received intra-articular corticosteroid injection in the last 3 months before inclusion;
- Patients with uncontrolled neurological or psychiatric disease;
- Patients with uncontrolled diabetes;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Cooled radiofrequency in classical targets (CRF-CT), Cooled radiofrequency in revised targets (CRF-RT)
- Keywords
- Knee Osteoarthritis, denervation of sensory nerves of the knee, classical targets, revised targets
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooled radiofrequency in classical targets (CRF-CT)Procedure or surgery
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.
Cooled radiofrequency in revised targets (CRF-RT)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Cooled radiofrequency in revised targets (CRF-RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Secondary outcomes (1)
Analyze the lesions of the neurotomized nerves
After the CRF procedure, patients will undergo MRI. The images will be evaluated for the characterization of the nerve lesions.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Sep 2022
- Primary completion31 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Alfenas
- Sponsor type
- University, hospital or other
- Collaborators
- SINPAIN LTDA
- Responsible party
- Principal investigator, Rafaela Figueiredo Rodriques, Universidade Federal de Alfenas
- Investigators
- Rafaela F Rodrigues, Ph.D, Principal investigator, Universidade Federal de AlfenasCarlos Marcelo de Barros, MD, FIPP, Study chair, Sinpain Ltda; Universidade Federal de AlfenasRanielly A Andrade, MD, Study chair, Santa Casa de AlfenasLúcio César H Silva, MD,FIPP,CIPS, Study chair, SINPAIN LTDACharles A de Oliveira, MD,FIPP, Study chair, SINPAIN LTDAPaulo Renato B da Fonseca, MD,FIPP,MBA, Study chair, SINPAIN LTDAFabrício D Assis, MD,FIPP, Study chair, SINPAIN LTDATiago S Freitas, MD,Ph.D,FIPP, Study chair, SINPAIN LTDA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363241
- Sponsor's protocol ID
- 5.354.533
- Status last verified
- Apr 2026
- First submitted
- 3 May 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33604437Fonkoue 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.
PubMed 31451628Fonkoue 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.
PubMed 31338537Fonkoue 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.
PubMed 32561652Gonzalez 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.
PubMed 33308582
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05363241
- Acronym / sponsor ID
- 5.354.533
- Conditions
- Osteoarthritis, Knee, Pain, Chronic, Analgesia
- Keywords
- Knee Osteoarthritis, denervation of sensory nerves of the knee, classical targets, revised targets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal de AlfenasUniversity, hospital or other
- Collaborators
- SINPAIN LTDA
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Cooled radiofrequency in classical targets (CRF-CT)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. |
| Radiofrequency cooled group with revised targets (CRF-RT) | Experimental | Procedure: Cooled radiofrequency in revised targets (CRF-RT)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 chronic knee pain for more than 3 months at the time of inclusion;
- 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.
Key exclusion criteria (11 listed)
- Patients younger than 40 years old, even if diagnosed with knee OA;
- Patients not diagnosed through imaging tests with OA;
- Patients who have undergone previous knee surgery in the last 3 months before inclusion;
- Patients who have received intra-articular corticosteroid injection in the last 3 months before inclusion;
- Patients with uncontrolled neurological or psychiatric disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Radiofrequency cooled group with classical targets (CRF-CT) |
| 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. | Procedure or surgery | Radiofrequency cooled group with revised targets (CRF-RT) |
Primary outcome
Analyze the efficacy of cooled radiofrequency in patients with chronic knee osteoarthritis pain.
Time frame: 7 months
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.
1 secondary outcome
Analyze the lesions of the neurotomized nerves
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 33604437Carlone 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.
- Background: PubMed 31451628Fonkoue 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.
- Background: PubMed 31338537Fonkoue 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.
- Background: PubMed 32561652Fonkoue 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.
- Background: PubMed 33308582Gonzalez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafaela F Rodrigues, Ph.D principal investigator
Universidade Federal de Alfenas
Carlos Marcelo de Barros, MD, FIPP study chair
Sinpain Ltda; Universidade Federal de Alfenas
Ranielly A Andrade, MD study chair
Santa Casa de Alfenas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooled radiofrequency in classical targets (CRF-CT) and Cooled radiofrequency in revised targets (CRF-RT) in people with Osteoarthritis, Knee and Pain, Chronic, run by Universidade Federal de Alfenas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the efficacy of cooled radiofrequency in patients with chronic knee osteoarthritis pain. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05363241, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.