Revised Targets for Knee Radiofrequency Ablation

NCT06934421 | Recruiting

• 1 other identifier: 025/2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This research team is doing a study to learn more about a new way to treat long-term knee pain caused by joint damage. They are using a treatment called radiofrequency ablation (RFA). This is a procedure where doctors use heat to stop certain nerves from sending pain signals. In this study, doctors will use ultrasound to guide a small needle to nerves around the knee, called genicular nerves. Then, they will apply heat to those nerves using radiofrequency energy to help reduce pain. The team created this new method based on recent studies of knee anatomy. They want to find out if this method can safely reduce pain and help people with knee joint damage move better. The study includes people who have moderate to severe knee damage and still have pain after trying medicine, physical therapy, or joint injections. Each person in the study will have the treatment once. The research team will follow each person for two years. During this time, people in the study will answer simple questions about their knee pain and how it affects their daily life. The researchers will collect this information before the treatment and several times after it. One week after the procedure, the team will call each person to ask how they are feeling and check for any side effects. Possible benefits of the study include less knee pain and easier movement. Possible risks include pain during the procedure, bruising, swelling, or short-term worsening of pain. Rare risks include nerve problems, weakness, bone damage, or allergic reaction. The study is free for participants, and there is no payment. Taking part is voluntary. Anyone can stop being in the study at any time without affecting their medical care. The research team will keep all personal information private and secure.

Conditions

Osteoarthritis Knee Pain

Keywords

Genicular nerve; Knee pain; Chronic pain; Knee osteoarthritis; Radiofrequency ablation; Ultrasound guidance; Interventional pain management; Joint degeneration; Nerve ablation; Image-guided procedures; Non-surgical treatment; Musculoskeletal intervention; Pain reduction; Functional improvement

Outcome Measures

Primary Outcomes (1)

• Change in Knee Pain Intensity (Numeric Pain Rating Scale - NPRS)

  Change in patient-reported knee pain at rest and during movement, measured using an 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain).

  Baseline to 3 months post-procedure

Secondary Outcomes (4)

• Change in Physical Function (WOMAC Functional Subscale)

  Baseline to 3 months, 6 months, 1 year, and 2 years post-procedure

• Sustained Pain Reduction (Numeric Pain Rating Scale)

  Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years post-procedure

• Incidence of Adverse Events

  From procedure day to 2-year follow-up

• Responder Rate (≥50% Pain Reduction)

  Baseline to 3 months post-procedure

Study Arms (1)

Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo

Participants with knee osteoarthrosis (Kellgran-Lawrence III or IV) will receive a single-session ultrasound-guided radiofrequency ablation of the genicular nerves. The procedure targets three specific nerve branches around the knee joint: the superomedial, superolateral, and inferomedial genicular nerves. The targeted positions are based on anatomical reference points described by Fonkoue et al. (2021) and validated in cadaveric studies, aiming to improve the accuracy of nerve localization. Under ultrasound guidance, the clinician will insert a radiofrequency needle at each target site. After confirming correct positioning through sensory and motor stimulation, thermal ablation will be performed at 85ºC for 90 seconds per site. Local anesthesia will be administered before each ablation to ensure patient comfort. This procedure aims to reduce knee pain and improve function in patients with moderate to severe knee joint degeneration who have not responded to conservative treatments.

Device: Ultrasound-Guided Genicular Nerve Radiofrequency Ablation

Interventions

Ultrasound-Guided Genicular Nerve Radiofrequency Ablation DEVICE

This intervention involves a single-session ultrasound-guided thermal radiofrequency ablation of the superomedial, superolateral, and inferomedial genicular nerves in patients with moderate to severe knee osteoarthritis. Target points follow anatomical references described by Fonkoue et al. and validated in cadaveric studies, differing from classical approaches. Under ultrasound guidance, monopolar RF cannulas are placed, with sensory and motor stimulation confirming accurate positioning. Local anesthesia (2% lidocaine) is applied. Lesions are performed at 85°C for 90 seconds per site. The radiofrequency generator used is CE-marked for pain procedures. The study evaluates a novel targeting protocol, not the safety or effectiveness of the device itself. No fluoroscopy is used. The procedure is performed once. Participants are followed for two years to assess outcomes.

Also known as: Thermal Radiofrequency Ablation of Genicular Nerves, Monopolar Radiofrequency Ablation of Knee Nerves, Image-Guided Genicular Nerve Ablation, Ultrasound-Guided RFA of Knee, Genicular Nerve RFA, RFA for Knee Osteoarthritis Pain

Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo

Eligibility Criteria

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

Study Population

Patients from the community referred to the Physical and Rehabilitation Medicine department.

You may qualify if:

• Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence (KL) grade III or IV, who are refractory to conservative treatment.
• (Refractoriness to conservative treatment is defined as:
• Persistent pain and functional limitation after undergoing knee-targeted physiotherapy and analgesic medication in accordance with clinical guidelines for osteoarthritis \[e.g., paracetamol, nonsteroidal anti-inflammatory drugs, and other drugs as deemed appropriate by the treating physician\];
• Persistent pain and functional limitation after intra-articular corticosteroid injections or limited success with such interventions.)

You may not qualify if:

• Patients with previous knee arthroplasty
• Patients who have undergone prior radiofrequency (RF) ablation
• Significant psycho-emotional disorders
• Addictive behaviors
• Generalized pain
• Nociplastic pain
• Presence of a pacemaker
• Presence of osteosynthesis material in the knee or adjacent anatomical regions

Sponsors & Collaborators

• Centro Hospitalar Universitario do Algarve: lead

Study Sites (2)

Serviço de Medicina Física e de Reabilitação - Hospital de Faro - Unidade Local de Saúde do Algarve

Faro, 8000-386, Portugal

RECRUITING

Serviço de Medicina Física e de Reabilitação - Hospital de São Francisco Xavier - Unidade Local de Saúde de Lisboa Ocidental

Lisbon, 1449-005, Portugal

NOT YET RECRUITING

Related Publications (7)

• Cohen SP, Bhaskar A, Bhatia A, Buvanendran A, Deer T, Garg S, Hooten WM, Hurley RW, Kennedy DJ, McLean BC, Moon JY, Narouze S, Pangarkar S, Provenzano DA, Rauck R, Sitzman BT, Smuck M, van Zundert J, Vorenkamp K, Wallace MS, Zhao Z. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med. 2020 Jun;45(6):424-467. doi: 10.1136/rapm-2019-101243. Epub 2020 Apr 3.

  PMID: 32245841 BACKGROUND

• Pardal, Margarida Alexandra Rodrigues. Adaptação cultural para português europeu do Western Ontario and McMaster Universities Arthritis Index (WOMAC). Master's Thesis 2023;

  BACKGROUND

• De Cassai A, Dost B, Tulgar S. Enhancing the clarity and reproducibility of regional anesthesia techniques: a call for video integration in scientific publications. Reg Anesth Pain Med. 2025 Oct 6;50(10):842-843. doi: 10.1136/rapm-2024-105871. No abstract available.

  PMID: 39043621 BACKGROUND

• Tran J, Peng P, Agur A. Evaluation of nerve capture using classical landmarks for genicular nerve radiofrequency ablation: 3D cadaveric study. Reg Anesth Pain Med. 2020 Nov;45(11):898-906. doi: 10.1136/rapm-2020-101894. Epub 2020 Sep 14.

  PMID: 32928998 BACKGROUND

• Tran J, Peng PWH, Chan VWS, Agur AMR. Overview of Innervation of Knee Joint. Phys Med Rehabil Clin N Am. 2021 Nov;32(4):767-778. doi: 10.1016/j.pmr.2021.05.011. Epub 2021 Jul 14.

  PMID: 34593142 BACKGROUND

• Fonkoue L, Stoenoiu MS, Behets CW, Steyaert A, Kouassi JK, Detrembleur C, Cornu O. Validation of a new protocol for ultrasound-guided genicular nerve radiofrequency ablation with accurate anatomical targets: cadaveric study. Reg Anesth Pain Med. 2021 Mar;46(3):210-216. doi: 10.1136/rapm-2020-101936. Epub 2020 Dec 3.

  PMID: 33273065 BACKGROUND

• Fonkoue L, Behets C, Kouassi JK, Coyette M, Detrembleur C, Thienpont E, Cornu O. Distribution of sensory nerves supplying the knee joint capsule and implications for genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat. 2019 Dec;41(12):1461-1471. doi: 10.1007/s00276-019-02291-y. Epub 2019 Jul 23.

  PMID: 31338537 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Osteoarthritis, Knee

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Manuel Tomás Farinha Caroço, Medical Doctor

  Unidade Local de Saude do Algarve / Centro Hospitalar Universitario Algarve

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel Tomás Farinha Caroço, Medical Doctor

CONTACT

+351968010683; farinhacaroco@gmail.com

Giovanni Leoni, Medical Doctor

CONTACT

+39 328 613 3631; gioleoni95@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 18, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): July 14, 2028
• Study Completion (Estimated): July 30, 2031
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Individual participant data (IPD) and supporting information will be available beginning 6 months after publication of the primary results. Data will remain available for a period of 5 years.
• Access Criteria: Researchers who wish to access individual participant data (IPD) must submit a written request including a clear research question, rationale, and a detailed statistical analysis plan. The proposed analyses must be scientifically sound, ethically appropriate, and feasible given the dataset. Proposals must demonstrate consistency with the objectives of academic, non-commercial research. All requests will be reviewed by the principal investigator and the study's coordinating research team to ensure alignment with ethical standards and scientific merit. If the request is approved, the researcher will be required to sign a data sharing agreement that outlines the terms of use, including data confidentiality, appropriate use, and prohibition of re-identification. Approved data will be shared in de-identified format through a secure institutional repository or via encrypted file transfer. Requests and supporting documents can be submitted by email to the principal investigator.

Locations

PT (2)