NCT05920382 Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.

Eligibility & Interventions

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This trial targets 86 participants in total. It began in 2023-09-25 with a primary completion date of 2026-09-01.

Brief Summary

Knee osteoarthritis pain is one of the conditions commonly seen in general and specialized medicine. Knee arthroplasty is one of the most successful orthopedic surgeries for the treatment of this disease, significantly improving pain, disability, and the overall quality of life for patients who undergo it. However, there is a subgroup of individuals in whom the pain persists or even worsens. Radiofrequency has been introduced over 10 years ago as a neuroablative technique targeting the genicular nerves, which innervate the sensory terminals of the knee joint, for the treatment of chronic pain in that region before or after arthroplasty. However, the results have not been entirely consistent. Recent anatomical studies have demonstrated the presence of other sensory terminal branches of the femoral nerve, such as the infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, and lateral vastus nerve, which could be useful targets for the treatment of post-knee arthroplasty pain. To date, no studies have been conducted to address post-knee arthroplasty pain through the application of thermal radiofrequency on the sensory branches of the knee from the femoral nerve (infrapatellar branch of the saphenous nerve, medial vastus nerve, intermediate vastus nerve, lateral vastus nerve). Therefore, The investigators aim to conduct a randomized double-blind clinical trial where The investigators will apply thermal radiofrequency on the sensory terminal branches of the femoral nerve in the knee, based on recent anatomical studies. The objective of the study is to determine if radiofrequency ablation of sensory nerves in the knee improves pain and disability in patients with post-knee arthroplasty chronic pain at the L'Alt Penedés-Garraf Health Consortium. Method: This is a randomized double-blind clinical trial with two arms. Two groups will be used, where one group will receive thermal radiofrequency of sensory nerves in the knee, and the other group will receive a placebo treatment. The hypothesis The investigators propose is that radiofrequency ablation will alleviate at least 50% of baseline pain and disability in at least 50% of the patients.

Eligibility Criteria

Inclusion Criteria: * Individuals who have undergone knee arthroplasty. * Chronic knee pain post-knee arthroplasty for at least 6 months after the procedure and less than 5 years. * Pain intensity on the numerical visual scale ≥ 5 out of 10 points. * Stable pain for the last 30 days. * The knee is the location with the highest intensity of pain, in the case of patients with multiple joint pains. Exclusion Criteria: * Acute knee pain. * Psychiatric illness or dementia that may interfere with or hinder study assessments. * Diagnosis of fibromyalgia, chronic fatigue syndrome, or central sensitization syndrome. * Knee infiltration with corticosteroids in the past 30 days. * Changes in oral analgesic medication in the past 30 days.

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