Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain. a Randomized Double-blind Study. a Novel Approach.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Consorci Sanitari Alt'Pènedes i Garraf
RECRUITING
Barcelona
Contact Information
Primary
ITALO G PISANI, MD
italopisani1976@gmail.com
+34649034623
Backup
ALEJANDRO RODRIGUEZ, PHD
ARODRIGUEZ@CSAPG.CAT
+34607214125
Time Frame
Start Date: 2023-09-25
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 86
Treatments
Experimental: Radiofrequency arm
After identifying the nerves to be treated via ultrasound and confirming with neurostimulation, 1 ml of 2% lidocaine will be administered, followed by radiofrequency ablation. The physical parameters used are as follows: 90 seconds, 80 degrees Celsius, with a 22g needle with an active tip of 10 mm.
Sham_comparator: Control arm
In the same manner as with the RF group, the nerves to be treated are identified via ultrasound and confirmed by neurostimulation. Subsequently, sham radiofrequency is performed for 90 seconds.
Sponsors
Leads: Consorci Sanitari de l'Alt Penedès i Garraf

This content was sourced from clinicaltrials.gov