Genicular Nerve Radiofrequency Ablation Versus Hyaluronic Acid Injection for Knee Osteoarthritis Pain (RF-PROSPECTIU)
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.
Обзор исследования
Статус
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Laura Pallares Valls, MD
- Номер телефона: +34 646973140
- Электронная почта: laura-pallares@hotmail.com
Учебное резервное копирование контактов
- Имя: Marta Sabater Martos, PhD
- Номер телефона: 676625869
- Электронная почта: Sabaterms@gmail.com
Места учебы
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Tarragona
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Tarragona, Tarragona, Испания, 43005
- Hospital Universitari Joan XXIII de Tarragona
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Контакт:
- Laura Pallarès Valls, MD
- Номер телефона: +34 646973140
- Электронная почта: lpallares.hj23.ics@gencat.cat
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
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). |
|
Активный компаратор: 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. |
Single 6 ml intra-articular injection of high molecular weight hyaluronic acid into the index knee. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Knee Pain During Movement (Visual Analogue Scale)
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Knee Pain at Rest (Visual Analogue Scale)
Временное ограничение: 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)
Временное ограничение: 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
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Proportion of Participants Achieving the Minimal Clinically Important Difference in Pain
Временное ограничение: 1, 3, 6 and 12 months after the intervention
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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
|
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Analgesic Consumption
Временное ограничение: Baseline, 1, 3, 6 and 12 months after the intervention
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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
|
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Number of Participants With Adverse Events
Временное ограничение: Up to 12 months after the intervention
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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
|
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Retreatment or Rescue Treatment
Временное ограничение: Up to 12 months after the intervention
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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
|
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Health-Related Quality of Life (EQ-5D-5L)
Временное ограничение: Baseline, 6 and 12 months after the intervention
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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
|
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Rate of Negative Diagnostic Genicular Nerve Blocks
Временное ограничение: 4 hours after the diagnostic block
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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
|
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Patient Global Assessment
Временное ограничение: Baseline, 1, 3, 6 and 12 months after the intervention
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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
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Patient Global Impression of Change (PGIC)
Временное ограничение: 1, 3, 6 and 12 months after the intervention
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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
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Proportion of OMERACT-OARSI Responders
Временное ограничение: 1, 3, 6 and 12 months after the intervention
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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
|
Соавторы и исследователи
Следователи
- Главный следователь: Laura Pallarès Valls, MD, Hospital Universitari Joan XXIII de Tarragona.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- Ceim-116/2026
- 116/2026 (Другой идентификатор: CEIm IISPV (Research Ethics Committee) reference number)
Планирование данных отдельных участников (IPD)
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Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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