Revised Targets for Knee Radiofrequency Ablation
Recruiting · NCT06934421 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centro Hospitalar Universitario do Algarve
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.)
Exclusion criteria
- Patients with previous knee arthroplasty
- Patients who have undergone prior radiofrequency (RF) ablation
- Significant psycho-emotional disorders
- Addictive behaviors
- Generalized pain
- Nociplastic pain
- Presence of a pacemaker
- Presence of osteosynthesis material in the knee or adjacent anatomical regions
Where it is running
2 locations listed.
- Serviço de Medicina Física e de Reabilitação - Hospital de Faro - Unidade Local de Saúde do Algarve - Faro, Portugal
- Serviço de Medicina Física e de Reabilitação - Hospital de São Francisco Xavier - Unidade Local de Saúde de Lisboa Ocidental - Lisbon, Portugal