Gonarthrosis
Conditions
Keywords
gonarthrosis, genicular nerves, radiofrequency ablation, ultrasound
Brief summary
Patients with chronic knee osteoarthritis who do not respond adequately to conservative treatment may benefit from genicular nerve radiofrequency ablation procedures. Both bipolar radiofrequency ablation (BPRFA) and cooled radiofrequency ablation (CRFA) are minimally invasive techniques used to reduce pain and improve knee function by targeting the genicular nerves. However, comparative data regarding their clinical outcomes remain limited. This prospective observational comparative study aims to evaluate the analgesic efficacy and safety of ultrasound-guided BPRFA and CRFA in patients with chronic gonarthrosis. Patients with moderate-to-severe chronic knee pain who achieve significant pain relief following diagnostic genicular nerve block subsequently undergo either BPRFA or CRFA targeting the superior medial, superior lateral, and inferior medial genicular nerves under ultrasound guidance. Pain intensity, functional status, kinesiophobia, and quality of life are assessed using the Numeric Rating Scale (NRS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Tampa Scale for Kinesiophobia (TSK), and the 12-Item Short Form Health Survey (SF-12) at baseline and during follow-up evaluations at 3, 12, and 24 weeks after treatment. The study compares pain reduction, functional improvement, treatment responder rates, quality-of-life outcomes, and procedure-related adverse events between the two treatment modalities.
Detailed description
Chronic knee osteoarthritis (gonarthrosis) is a major cause of persistent pain, reduced mobility, and impaired quality of life, particularly in older adults. Although conservative treatment options such as physical therapy, oral analgesics, and intra-articular injections are commonly used, many patients continue to experience significant pain and functional limitation. In recent years, genicular nerve radiofrequency ablation techniques have emerged as effective minimally invasive alternatives for patients who do not achieve adequate benefit from conservative management or are not suitable candidates for surgery. Bipolar radiofrequency ablation (BPRFA) and cooled radiofrequency ablation (CRFA) are two radiofrequency techniques designed to create larger and more effective lesions around the genicular nerves, potentially improving denervation of the complex and variable sensory innervation of the knee joint. While both methods have shown promising results in the treatment of chronic knee osteoarthritis pain, direct comparative data regarding their clinical efficacy, functional outcomes, and safety profiles remain limited. This prospective observational comparative study aims to evaluate and compare the analgesic efficacy and safety of ultrasound-guided BPRFA and CRFA in patients with chronic gonarthrosis refractory to conservative treatment. Patients with moderate-to-severe unilateral knee pain who achieve significant pain relief following diagnostic genicular nerve block subsequently undergo either BPRFA or CRFA targeting the superior medial, superior lateral, and inferior medial genicular nerves under ultrasound guidance as part of routine clinical practice. Clinical outcomes are assessed using multiple validated outcome measures. Pain intensity is evaluated using the Numeric Rating Scale (NRS), functional status is assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), kinesiophobia is evaluated using the Tampa Scale for Kinesiophobia (TSK), and quality of life is assessed using the 12-Item Short Form Health Survey (SF-12). Assessments are performed at baseline and during follow-up visits at 3, 12, and 24 weeks after treatment. The study aims to compare pain reduction, functional recovery, quality-of-life improvement, treatment responder rates, and procedure-related adverse events between BPRFA and CRFA in patients with chronic knee osteoarthritis.
Interventions
PROCEDUREBipolar Radiofrequency Ablation
Patients with chronic knee osteoarthritis refractory to conservative treatment will initially undergo an ultrasound-guided diagnostic genicular nerve block to assess treatment responsiveness. The superior medial, superior lateral, and inferior medial genicular nerves will be identified using anatomical landmarks and Doppler-confirmed genicular arteries with the Alpinion® E-Cube 8 Diamond ultrasound system equipped with a 3-12 MHz linear transducer. Following negative aspiration, a mixture of local anesthetics will be injected around each target nerve. Patients achieving at least 50% pain reduction for a minimum of 3 hours after the diagnostic block will subsequently undergo bipolar radiofrequency ablation (Bi-RFA). Bi-RFA procedures will be performed under sterile ultrasound guidance using the COOLIEF™ Cooled RF Advanced Generator. Two parallel 21-gauge radiofrequency cannulas with 10-mm active tips will be positioned adjacent to each target nerve to create larger bipolar lesions. App
PROCEDURECooled Radiofrequency Ablation
Cooled radiofrequency ablation (C-RFA) will be performed under ultrasound guidance with linear transducer. Procedures will be carried out using the COOLIEF™ Cooled RF Advanced Generator (Avanos Medical®, USA). Continuous cooling of the probe tip with a saline circulation system enables the creation of larger lesions while maintaining tissue temperature at approximately 60°C. Patients achieving at least 50% pain relief following the diagnostic genicular nerve block will undergo C-RFA targeting the superior medial, superior lateral, and inferior medial genicular nerves. Following sterile preparation and local anesthesia with 2% lidocaine, a cooled radiofrequency probe will be advanced to the target site under ultrasound guidance. Sensory and motor stimulation will be performed to confirm accurate needle placement before cooled thermal ablation is applied at 60°C for 150 seconds. Patients will be monitored for possible complications after the procedure.
Sponsors
Saglik Bilimleri Universitesi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants were assigned to either the BPRFA or CRFA group according to routine clinical practice and physician decision, and outcomes were prospectively compared between groups.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients with chronic knee osteoarthritis (gonarthrosis) who have persistent pain despite medical and conservative treatment and are considered appropriate candidates for radiofrequency ablation therapy will be included in the study after detailed explanation of the procedure and post-procedural follow-up process and after providing informed consent. Eligible participants must meet the following criteria: * Age between 40 and 75 years * Unilateral moderate-to-severe knee pain related to gonarthrosis (Numeric -Rating Scale \[NRS\] ≥6) * Persistent pain for longer than 6 months * Radiological evidence of Kellgren-Lawrence grade 2, 3, or 4 osteoarthritis * Inadequate response to conservative treatment modalities, including analgesic medications, intra-articular injections, and physical therapy * Impairment of daily living activities due to knee pain
Exclusion criteria
* Refusal to undergo the procedure or provide informed consent * Knee pain unrelated to osteoarthritis or absence of pain localized to the target knee region * Knee pain secondary to other conditions such as fracture, trauma, spinal disorders, or inflammatory arthritis * History of surgical intervention involving the target knee within the previous 6 months * History of intra-articular injection to the target knee within the previous 3 months, including corticosteroids, platelet-rich plasma, stem cell therapy, or hyaluronic acid * Absence of moderate-to-severe radiological gonarthrosis findings * Cognitive impairment limiting reliable assessment or cooperation * Hepatic or renal failure * Severe psychiatric disorders * Local or systemic infection * Coagulopathy * Current use of antiplatelet or anticoagulant medications * Presence of a cardiac pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity | Baseline, 3 weeks, 12 weeks, and 24 weeks | Pain intensity was assessed using the Numeric Rating Scale (NRS). Changes in NRS scores from baseline were evaluated after ultrasound-guided bipolar and cooled radiofrequency ablation of the genicular nerves. |
| Responder Rate Defined as ≥50% Reduction in NRS Scores | Baseline, 3 weeks, 12 weeks, and 24 weeks | Treatment response was defined as a reduction of at least 50% in Numeric Rating Scale (NRS) scores compared with baseline values following treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement | Baseline, 3 weeks, 12 weeks, and 24 weeks | Functional outcomes and quality of life were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), including total, pain, stiffness, and function subscale scores. |
| Change in Quality of Life | Baseline, 3 weeks, 12 weeks, and 24 weeks | Quality of life will be evaluated using the 12-Item Short Form Health Survey (SF-12). Changes in SF-12 scores compared with baseline values will be assessed during follow-up visits. |
| Change in Kinesiophobia | Baseline, 3 weeks, 12 weeks, and 24 weeks | Kinesiophobia and fear of movement associated with chronic knee pain will be assessed using the Tampa Scale for Kinesiophobia (TSK). Changes in TSK scores from baseline following treatment will be evaluated during follow-up visits. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFurkan Cetin, MD.
STUDY_DIRECTORAlp Eren Celenlioglu, MD./Assoc. Prof.
Department of Algology, University of Health Sciences Gulhane Training and Research Hospital, Ankara, Turkiye
Outcome results
None listed