Actively Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Led by Consorci Sanitari de l'Alt Penedès i Garraf · Updated on 2025-12-09
86
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals who have undergone knee arthroplasty
- Chronic knee pain after knee arthroplasty lasting at least 6 months and less than 5 years
- Pain intensity of 5 or higher on a 10-point numerical scale
- Stable pain for the last 30 days
- Knee is the location of the highest pain intensity if multiple joints are painful
You will not qualify if you...
- Acute knee pain
- Psychiatric illness or dementia that interfere with study assessments
- Diagnosis of fibromyalgia, chronic fatigue syndrome, or central sensitization syndrome
- Knee steroid injections within the past 30 days
- Changes in oral pain medication within the past 30 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Consorci Sanitari Alt'Pènedes i Garraf
Barcelona, Catalonia, Spain, 08810
Actively Recruiting
Research Team
I
ITALO G PISANI, MD
CONTACT
A
ALEJANDRO RODRIGUEZ, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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