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Actively Recruiting

Age: 18Years +
All Genders
ID06934421

Safety and Effectiveness of a New Ultrasound-Guided Radiofrequency Ablation Approach for Genicular Nerves in Knee Osteoarthritis

Led by Centro Hospitalar Universitario do Algarve · Updated on 2025-04-24

60

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a new ultrasound-guided radiofrequency ablation RFA method for treating long-term knee pain caused by joint damage, specifically moderate to severe osteoarthritis. This study focuses on a novel targeting protocol for the genicular nerves around the knee, based on recent anatomical research to improve accuracy and consistency in nerve localization. The aim is to see if this new approach can safely reduce pain and improve movement for people who have not found relief from medicines, physical therapy, or joint injections. Participants will receive a single-session ultrasound-guided thermal RFA treatment targeting three specific genicular nerve branches around the knee. The procedure uses local anesthesia and involves inserting radiofrequency needles under ultrasound guidance. Sensory and motor stimulations confirm correct needle placement before applying heat at 85C for 90 seconds at each site. This approach avoids fluoroscopy and follows updated anatomical landmarks to enhance precision. The treatment session is one-time, with follow-up scheduled for two years. During the study, participants will complete questionnaires about their knee pain and function before treatment and multiple times afterward. Researchers will monitor changes in pain intensity, physical function, and any side effects, including a phone call one week after the procedure to check for any adverse events. The primary outcome is pain change at three months, with additional assessments extending up to two years. The study is free to join, voluntary, and all personal information is kept confidential.

CONDITIONS

Brief Title

Revised Targets for Knee Radiofrequency Ablation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence grade III or IV
  • Pain and functional limitation that persists after knee-targeted physiotherapy and analgesic medications
  • Pain and functional limitation that persists after intra-articular corticosteroid injections or limited success with such treatments
Not Eligible

You will not qualify if you...

  • Previous knee replacement surgery
  • Prior radiofrequency ablation treatment on the knee
  • Significant psycho-emotional disorders
  • Addictive behaviors
  • Generalized pain conditions
  • Nociplastic pain
  • Presence of a pacemaker
  • Presence of osteosynthesis material in the knee or nearby areas

Research Team

M

Manuel Tomás Farinha Caroço, Medical Doctor

G

Giovanni Leoni, Medical Doctor

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