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Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain (RF-PROSPECTIU)

11 november 2026 bijgewerkt door: Laura Pallarès Valls, Hospital Universitari Joan XXIII de Tarragona.

A Prospective Comparative Study of Conventional Conservative Treatment Versus Genicular Radiofrequency Ablation in Non-Surgical Knee Osteoarthritis: A Randomized Controlled Trial of Thermal Radiofrequency of the Genicular Nerves Versus Intra-Articular Hyaluronic Acid

The goal of this clinical trial is to learn if thermal radiofrequency ablation of the genicular nerves (the nerves that carry pain signals from the knee) works better than a single injection of hyaluronic acid into the knee to relieve pain in adults with knee osteoarthritis who have not improved with conservative treatment. The study also includes patients with severe knee osteoarthritis who are not candidates for knee replacement surgery.

The main questions it aims to answer are:

  • Does genicular nerve radiofrequency reduce knee pain during movement more than hyaluronic acid over 12 months?
  • Does it improve knee function and quality of life, and does its effect last longer?

Researchers will compare radiofrequency ablation with hyaluronic acid injection to see which treatment gives greater and longer-lasting pain relief.

Participants will:

  • Be randomly assigned to one of the two treatments.
  • If assigned to radiofrequency, first receive a diagnostic nerve block with local anesthetic. Only those whose pain decreases by at least 50% will then receive radiofrequency ablation, in a single ultrasound-guided session.
  • If assigned to hyaluronic acid, receive a single injection of hyaluronic acid into the knee.
  • Attend follow-up visits at 1, 3, 6 and 12 months, where they will rate their pain and answer questionnaires about knee function, overall status and quality of life.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Knee osteoarthritis is a leading cause of chronic pain and disability. Conventional conservative treatments, such as non-steroidal anti-inflammatory drugs and intra-articular hyaluronic acid, provide partial and time-limited relief. Thermal radiofrequency ablation of the genicular nerves is a minimally invasive technique that interrupts pain transmission from the knee joint. Most published studies have short follow-up (3-6 months), and evidence is scarce in patients with advanced osteoarthritis (Kellgren-Lawrence grade IV) who are not candidates for total knee arthroplasty because of severe comorbidity, morbid obesity or a documented multidisciplinary decision.

Design: single-center, randomized, parallel-group (1:1) controlled trial conducted at Hospital Universitari Joan XXIII de Tarragona (Spain). Patients and clinicians are not blinded; the outcome assessor and the statistician are blinded to treatment allocation.

Randomization: computer-generated sequence (sealedenvelope.com) with variable block sizes, stratified by Kellgren-Lawrence grade (II-III vs IV) and body mass index (<40 vs >=40 kg/m2).

Interventions: in the radiofrequency group, an ultrasound-guided diagnostic block of the superomedial, superolateral and inferomedial genicular nerves (1 ml of 1% lidocaine per nerve) is performed first. Patients with at least 50% pain reduction within 4 hours undergo ultrasound-guided thermal radiofrequency ablation of the same nerves (80 C for 90 seconds per nerve). Patients with a negative block do not receive radiofrequency, are withdrawn from the study and are reported in the CONSORT flow diagram. In the hyaluronic acid group, patients receive a single 6 ml intra-articular injection of high molecular weight hyaluronic acid (hylan G-F 20 or similar).

Sample size: 25 patients per group are required to detect a minimal clinically important difference of 2 points in the visual analogue scale (standard deviation 2.5, power 80%, two-sided alpha 0.05). Allowing for 20% losses over 12 months, 35 patients per group (70 in total) will be included.

A pre-specified subgroup analysis will compare treatment response in Kellgren-Lawrence grade II-III versus grade IV patients, and according to comorbidity (Charlson Comorbidity Index) and body mass index. Health-related quality of life data will be collected for a potential cost-effectiveness analysis.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Spanje
    • Tarragona
      • Tarragona, Tarragona, Spanje, 43005
        • Hospital Universitari Joan XXIII de Tarragona
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Adults (18 years or older) with symptomatic knee osteoarthritis of more than 6 months' duration.
  • Pain during movement >4 on a 0-10 visual analogue scale.
  • Failure of conservative treatment: pain during movement >4 despite at least 3 months of NSAIDs and/or rehabilitation (physical therapy), documented in the medical record. Patients with a documented contraindication to NSAIDs may be included if they have undergone rehabilitation.
  • Radiographic Kellgren-Lawrence grade II or III, or
  • Kellgren-Lawrence grade IV in patients who are not candidates for total knee arthroplasty because of at least one of the following: body mass index >39.9 kg/m2; Charlson Comorbidity Index >=5 (original, not age-adjusted); or a documented multidisciplinary decision of the Orthopaedic Surgery Department.
  • Signed informed consent.

Exclusion Criteria:

  • Acute or chronic knee joint infection.
  • Intra-articular hyaluronic acid or corticosteroid injection in the previous 6 months.
  • Coagulopathy or anticoagulant treatment that does not allow a safe therapeutic window for the procedure.
  • Major lower limb surgery in the previous 6 months that may affect function or pain of the index knee (including contralateral total or partial knee arthroplasty, hip arthroplasty, or tibial or femoral osteotomy).
  • Cardiac pacemaker or metallic implant (contraindication for radiofrequency).
  • Known allergy to hyaluronic acid.
  • Severe dementia.
  • Institutionalized patients.
  • Decompensated systemic disease.
  • Active neurological or inflammatory rheumatological disease.
  • Terminal oncological disease.
  • Inability to understand the study questionnaires.
  • Radiofrequency arm only: negative diagnostic genicular nerve block (<50% pain reduction within 4 hours).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Genicular Nerve Radiofrequency Ablation

Ultrasound-guided diagnostic block of the superomedial, superolateral and inferomedial genicular nerves with 1 ml of 1% lidocaine per nerve. Participants with at least 50% pain reduction within 4 hours undergo ultrasound-guided thermal radiofrequency ablation of the same three nerves (80 C for 90 seconds per nerve) in a single session. Participants with a negative block do not receive radiofrequency and are withdrawn from the study.
Procedure: Thermal Radiofrequency Ablation of the Genicular Nerves

Ultrasound-guided thermal radiofrequency ablation (80 C, 90 seconds per nerve) of the superomedial, superolateral and inferomedial genicular nerves, performed only after a positive diagnostic block (>=50% pain reduction within 4 hours after 1 ml of 1% lidocaine per nerve).
Actieve vergelijker: Intra-articular Hyaluronic Acid

Single intra-articular injection of 6 ml of high molecular weight hyaluronic acid (hylan G-F 20, Synvisc-One, or similar) into the index knee.
Apparaat: Intra-articular Hyaluronic Acid

Single 6 ml intra-articular injection of high molecular weight hyaluronic acid into the index knee.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Knee Pain During Movement (Visual Analogue Scale)
Tijdsspanne: Baseline, 1, 3, 6 and 12 months after the intervention

Pain during movement (walking or climbing stairs) in the index knee, measured on a 100 mm visual analogue scale and recorded in cm with one decimal (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
Baseline, 1, 3, 6 and 12 months after the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Knee Pain at Rest (Visual Analogue Scale)
Tijdsspanne: Baseline, 1, 3, 6 and 12 months after the intervention

Pain at rest in the index knee, measured on a 100 mm visual analogue scale and recorded in cm with one decimal (0 = no pain, 10 = worst imaginable pain). Higher scores indicate worse pain.
Baseline, 1, 3, 6 and 12 months after the intervention
Change in Knee Function (WOMAC)
Tijdsspanne: Baseline, 1, 3, 6 and 12 months after the intervention

Western Ontario and McMaster Universities Osteoarthritis Index (Likert 3.1). Total score 0-96 and subscales for pain (0-20), stiffness (0-8) and physical function (0-68). Higher scores indicate worse symptoms and function.
Baseline, 1, 3, 6 and 12 months after the intervention
Proportion of Participants Achieving the Minimal Clinically Important Difference in Pain
Tijdsspanne: 1, 3, 6 and 12 months after the intervention

Percentage of participants with a reduction of at least 2 points from baseline in pain during movement (visual analogue scale, 0-10).
1, 3, 6 and 12 months after the intervention
Analgesic Consumption
Tijdsspanne: Baseline, 1, 3, 6 and 12 months after the intervention

Number of days with analgesic use in the previous 4 weeks (0-28) and most potent analgesic used (none, paracetamol, NSAID, weak opioid, strong opioid).
Baseline, 1, 3, 6 and 12 months after the intervention
Number of Participants With Adverse Events
Tijdsspanne: Up to 12 months after the intervention

Adverse events related to the diagnostic block, radiofrequency ablation or hyaluronic acid injection, systematically recorded at each visit.
Up to 12 months after the intervention
Retreatment or Rescue Treatment
Tijdsspanne: Up to 12 months after the intervention

Proportion of participants requiring retreatment, rescue treatment (including corticosteroid injection) or indication of total knee arthroplasty, and time to first retreatment or rescue treatment.
Up to 12 months after the intervention
Health-Related Quality of Life (EQ-5D-5L)
Tijdsspanne: Baseline, 6 and 12 months after the intervention

EQ-5D-5L descriptive system (5 dimensions, 5 levels; utility index calculated with the Spanish value set, where 1 = full health and higher values indicate better health) and EQ-VAS (0-100, higher scores indicate better health).
Baseline, 6 and 12 months after the intervention
Rate of Negative Diagnostic Genicular Nerve Blocks
Tijdsspanne: 4 hours after the diagnostic block

Percentage of participants allocated to the radiofrequency arm with less than 50% pain reduction within 4 hours after the diagnostic block, who therefore do not receive radiofrequency ablation.
4 hours after the diagnostic block
Patient Global Assessment
Tijdsspanne: Baseline, 1, 3, 6 and 12 months after the intervention

Patient global assessment of the impact of knee osteoarthritis, measured on a 100 mm visual analogue scale (0 = very well, 100 = very poor). Higher scores indicate worse status.
Baseline, 1, 3, 6 and 12 months after the intervention
Patient Global Impression of Change (PGIC)
Tijdsspanne: 1, 3, 6 and 12 months after the intervention

Single 7-point item from "very much better" to "very much worse" compared with before the study treatment. Responders are participants reporting "much better" or "very much better".
1, 3, 6 and 12 months after the intervention
Proportion of OMERACT-OARSI Responders
Tijdsspanne: 1, 3, 6 and 12 months after the intervention

Responder according to OMERACT-OARSI criteria, based on pain during movement, WOMAC physical function and patient global assessment, each expressed on a 0-100 scale: improvement in pain or function >=50% and >=20 points, or improvement >=20% and >=10 points in at least two of the three domains.
1, 3, 6 and 12 months after the intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital Universitari Joan XXIII de Tarragona.

Medewerkers

Institut Investigacio Sanitaria Pere Virgili

Onderzoekers

  • Hoofdonderzoeker: Laura Pallarès Valls, MD, Hospital Universitari Joan XXIII de Tarragona.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 mei 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

21 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 oktober 2026

Eerst geplaatst (Werkelijk)

28 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

11 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Ceim-116/2026
  • 116/2026 (Andere identificatie: CEIm IISPV (Research Ethics Committee) reference number)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared publicly, as participant consent for data sharing was not obtained and data are protected under the EU General Data Protection Regulation (GDPR). Data will be pseudonymized using participant codes and entered into REDCap, where the statistical analysis will be performed. Aggregated results will be published in peer-reviewed journals.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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