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

NCT05920382 | Recruiting

• 1 other identifier: CSAPG-37
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post Operative Pain; Chronic Knee Pain; Chronic Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• Change Pain and Disability measured by Western Ontario and McMaster Universities Arthritis Index, (WOMAC).

  Determine if radiofrequency ablation of the medial vastus nerve, infrapatellar branch of the saphenous nerve, intermediate vastus nerve, and lateral vastus nerve improves pain and disability at 3 months compared to baseline, as measured by WOMAC questionnaire, in patients with post-knee arthroplasty pain, compared to patients treated with placebo. The WOMAC test consists of several questions that address different aspects related to pain and functionality of the affected joint. These questions are divided into three main domains: Pain, Stiffness, Physical function The change in test scores will be evaluated throughout the study period, comparing them to the baseline.

  3 month

Secondary Outcomes (7)

• Changes in pain measured by the Numeric Rating Scale for pain. (NRS)

  3 month

• Neuropathic pain measured by Neuropathic Pain questionnaire (DN4)

  3 month

• Depression and anxiety measured by Hospital Anxiety and Depression Scale (HADS)

  3 month

• Degree of satisfaction with the procedure performed measured by categorical satisfaction scale of our hospital's pain unit.

  3 month

• Safety from the applied treatment measured by number of adverse events associated with the technique.

  3 month

Study Arms (2)

Radiofrequency arm

EXPERIMENTAL

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.

Procedure: Radiofrequency ablation of peripheral nerves.

Control arm

SHAM COMPARATOR

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.

Procedure: Radiofrequency ablation of peripheral nerves.

Interventions

Radiofrequency ablation of peripheral nerves. PROCEDURE

Randomized double-blind clinical trial where we will apply thermal radiofrequency to the sensory terminal branches of the femoral nerve in the knee, including the vasto medial nerve, vasto lateral nerve, vasto intermedio nerves, and the infrapatellar branch of the saphenous nerve.

Also known as: Radiofrecuency arm, Sham arm

Control arm; Radiofrequency arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de l'Alt Penedès i Garraf: lead

Study Sites (1)

Consorci Sanitari Alt'Pènedes i Garraf

Barcelona, Catalonia, 08810, Spain

RECRUITING

Related Publications (1)

• Pisani-Zambrano IG, Segur-Vilalta JM, Orduna-Valls J, Rodriguez-Molinero A. Radiofrequency ablation for the treatment of chronic pain after knee arthroplasty: protocol for a randomized, double-blind study. Trials. 2026 Mar 25. doi: 10.1186/s13063-026-09585-8. Online ahead of print.

  PMID: 41882766 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• JOSEP M SEGUR, PHD

  BARCELONA UNIVERSITY

  STUDY DIRECTOR

Central Study Contacts

ITALO G PISANI, MD

CONTACT

+34649034623; italopisani1976@gmail.com

ALEJANDRO RODRIGUEZ, PHD

CONTACT

+34607214125; ARODRIGUEZ@CSAPG.CAT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The assessment of the results will be carried out by personnel hired for this purpose, who will be unaware of the patient's group allocation. Similarly, neither the investigators nor the collaborators present on the day of the intervention will be aware of the results of the applied technique. The data analysts will also be blinded to the study arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pain Unit

Model Details: Randomized double-blind clinical trial with two arms: Radiofrequency Arm (RFA): Thermal radiofrequency will be applied to the sensory nerves of the knee, along with local anesthetic and corticosteroid infiltration. Control Arm (CA): Simulated radiofrequency will be applied to the sensory nerves of the knee, along with local anesthetic and corticosteroid infiltration.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 27, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

ES (1)