Revised Targets for Knee Radiofrequency Ablation
ConditionOsteoarthritis Knee Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Hospitalar Universitario do Algarve
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with chronic knee pain related to radiographic knee osteoarthritis, Kellgren-Lawrence (KL) grade III or IV, who are refractory to conservative treatment.
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.)
Disqualifiers
Patients with previous knee arthroplasty
Patients who have undergone prior radiofrequency (RF) ablation
Significant psycho-emotional disorders
Addictive behaviors
Trial population
Patients from the community referred to the Physical and Rehabilitation Medicine department.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Ultrasound-Guided Genicular Nerve Radiofrequency Ablation
DeviceThis 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single-Session Ultrasound-Guided Genicular Nerve Radiofrequency Ablation in Patients With Knee Osteo1 intervention
Trial outcomes
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).
Time frame
Baseline to 3 months post-procedureSecondary outcomes
1
Change in Physical Function (WOMAC Functional Subscale)
Change in physical function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) - Physical Function Subscale. The WOMAC is a validated, self-reported questionnaire assessing functional limitations due to knee osteoarthritis. This subscale includes 17 items, each scored on a Likert scale from 0 to 4. The total score ranges from 0 to 68, with higher scores indicating worse physical function.
Time frame
Baseline to 3 months, 6 months, 1 year, and 2 years post-procedure2
Sustained Pain Reduction (Numeric Pain Rating Scale)
Change in pain intensity over time as measured by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst imaginable pain". Patients will report their average knee pain intensity over the past 24 hours. Higher scores indicate worse pain. This outcome assesses the duration and consistency of the analgesic effect following the radiofrequency ablation procedure.
Time frame
Baseline to 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years post-procedure3
Incidence of Adverse Events
Number and type of adverse events related to the intervention, including local site pain, edema, bruising, motor weakness, neuritis, or other complications.
Time frame
From procedure day to 2-year follow-up4
Responder Rate (≥50% Pain Reduction)
Proportion of participants achieving ≥50% reduction in NPRS at 3 months post-procedure compared to baseline.
Time frame
Baseline to 3 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov