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

11. listopadu 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

70

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Španělsko
    • Tarragona
      • Tarragona, Tarragona, Španělsko, 43005
        • Hospital Universitari Joan XXIII de Tarragona
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Postup: 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).
Aktivní komparátor: 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.
Přístroj: Intra-articular Hyaluronic Acid

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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Knee Pain During Movement (Visual Analogue Scale)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Knee Pain at Rest (Visual Analogue Scale)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hospital Universitari Joan XXIII de Tarragona.

Spolupracovníci

Institut Investigacio Sanitaria Pere Virgili

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. května 2028

Dokončení studie (Odhadovaný)

1. května 2028

Termíny zápisu do studia

První předloženo

21. října 2026

První předloženo, které splnilo kritéria kontroly kvality

21. října 2026

První zveřejněno (Aktuální)

28. října 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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