Segurança e eficácia de Nova Abordagem Ecoguiada de ablação Por radiofrequência Dos Nervos Geniculados

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

This research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals. In this study, doctors will use ultrasound to guide a small needle to nerves around the knee, called genicular nerves. Then, they will apply heat to those nerves using radiofrequency energy to help reduce pain. The team created this new method based on recent studies of knee anatomy. They want to find out if this method can safely reduce pain and help people with knee joint damage move better. The study includes people who have moderate to severe knee damage and still have pain after trying medicine, physical therapy, or joint injections. Each person in the study will have the treatment once. The research team will follow each person for two years. During this time, people in the study will answer simple questions about their knee pain and how it affects their daily life. The researchers will collect this information before the treatment and several times after it. One week after the procedure, the team will call each person to ask how they are feeling and check for any side effects. Possible benefits of the study include less knee pain and easier movement. Possible risks include pain during the procedure, bruising, swelling, or short-term worsening of pain. Rare risks include nerve problems, weakness, bone damage, or allergic reaction. The study is free for participants, and there is no payment. Taking part is voluntary. Anyone can stop being in the study at any time without affecting their medical care. The research team will keep all personal information private and secure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence (KL) grade III or IV, who are refractory to conservative treatment.

⁃ (Refractoriness to conservative treatment is defined as:

• Persistent pain and functional limitation after undergoing knee-targeted physiotherapy and analgesic medication in accordance with clinical guidelines for osteoarthritis \[e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and other drugs as deemed appropriate by the treating physician\];

• Persistent pain and functional limitation after intra-articular corticosteroid injections or limited success with such interventions.)

Locations
Other Locations
Portugal
Serviço de Medicina Física e de Reabilitação - Hospital de Faro - Unidade Local de Saúde do Algarve
RECRUITING
Faro
Serviço de Medicina Física e de Reabilitação - Hospital de São Francisco Xavier - Unidade Local de Saúde de Lisboa Ocidental
NOT_YET_RECRUITING
Lisbon
Contact Information
Primary
Manuel Tomás Farinha Caroço, Medical Doctor
farinhacaroco@gmail.com
+351968010683
Backup
Giovanni Leoni, Medical Doctor
gioleoni95@gmail.com
+39 328 613 3631
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2031-07-30
Participants
Target number of participants: 60
Treatments
Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo
Participants with knee osteoarthrosis (Kellgran-Lawrence III or IV) will receive a single-session ultrasound-guided radiofrequency ablation of the genicular nerves. The procedure targets three specific nerve branches around the knee joint: the superomedial, superolateral, and inferomedial genicular nerves. The targeted positions are based on anatomical reference points described by Fonkoue et al. (2021) and validated in cadaveric studies, aiming to improve the accuracy of nerve localization. Under ultrasound guidance, the clinician will insert a radiofrequency needle at each target site. After confirming correct positioning through sensory and motor stimulation, thermal ablation will be performed at 85ºC for 90 seconds per site. Local anesthesia will be administered before each ablation to ensure patient comfort. This procedure aims to reduce knee pain and improve function in patients with moderate to severe knee joint degeneration who have not responded to conservative treatments.
Related Therapeutic Areas
Sponsors
Leads: Centro Hospitalar Universitario do Algarve

This content was sourced from clinicaltrials.gov