RFA or Chemical Neurolysis of the Genicular Nerves Compared to Conservative Treatment for Knee Pain Caused by OA

Официальное название

Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol

Обзор

A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).

Подробное описание

In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases the golden standard is joint replacing surgery. A less invasive technique is ablation of the sensory (genicular) nerves of the knee. This technique is beneficial for younger patients as a bridge to surgery or patients that cannot undergo total knee arthroplasty (TKA) due to comorbid health conditions. Nerve ablation can either be done with chemical agents or thermal energy.

Although there are numerous studies on genicular nerve block for chronic knee pain caused by OA, there are just a few small studies that compare genicular nerve block with conservative treatment.To be able to determine if genicular nerve ablation is efficacious to serve the gap between conservative treatment and TKA, this randomised controlled trial (RCT) compares two forms of genicular nerve ablation (radiofrequency and phenolisation; intervention) with conservative treatment (control) up to 6 months after treatment.

Вмешательства

• Процедура Diagnostic genicular nerve block
  Diagnostic block will be done with 1,5ml of Lidocaine 2% at the 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve.
• Процедура Genicular nerve block with Radiofrequency Ablation (RFA)
  Genicular nerve block with RFA will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Radiofrequency ablation (RFA) is performed by creating two RFA lesions at the 3 treatment sites (6 lesions in total) after local anesthesia with 1,5ml lidocaine 2%. The lesions are made by heating the 5mm active tip of the needle to 80°C for 90 seconds.
• Процедура Genicular nerve block with Phenol 6%
  Genicular nerve block with Phenol 6% will be performed at 3 target sites: the superomedial, the superolateral and the inferomedial genicular nerve. Chemical ablation with phenol is done by injection of 1 ,5ml of phenol 6 % at the 3 target sites after infiltration with contrast dye to rule out intravascular injection. Because infiltration with phenol is painless, prior infiltration of the target site with al local anaesthetic is not necessary.

Первичные конечные точки

• Knee function measured with the Oxford Knee score (OKS) [Срок оценки: During intake, before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).]

Вторичные конечные точки (12)

• Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Срок оценки: Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).]
• Pain measured with the Numeric Rating Score (NRS) [Срок оценки: In rest during intake and in rest and during performance based tests before and after the diagnostic nerve block (if applicable), before the intervention (if applicable), 6 weeks, 3 months, 6 months and 1 year after the intervention]
• 30 seconds chair-stand test [Срок оценки: Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.]
• 40 meters (4x10m) fast-paced walk test [Срок оценки: Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.]
• 9-steps stair-climb test [Срок оценки: Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.]
• Health related quality of life with the EQ-5D-5L [Срок оценки: Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: At T=0 (before intervention) and during T=3 (6 months after intervention)]
• Pain Catastrophizing Score (PCS) [Срок оценки: At T=0 (before intervention) and during T=3 (6 months after intervention)]
• Diagnostic block most appropriate cut-off value [Срок оценки: Before and after the diagnostic block and during T=2 (3 months after intervention).]
• Patient satisfaction [Срок оценки: During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).]
• Patient Global Impression of Change (PGIC) [Срок оценки: During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).]
• Minimal Clinically Important Difference (MCID) of the OKS [Срок оценки: MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up. .]

Критерии участия

Критерии включения

• Adult patients of both sexes, >35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
• OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
• Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration.
• Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.

Критерии исключения

• Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
• Patient with a history of neurovascular injury or recent trauma of the lower extremities.
• Patient with chronic widespread pain.
• Polyneuropathy and/or radicular pain in the lower extremities.
• Patient is currently implanted with a neurostimulator.
• Local or systemic infection (bacteraemia).
• Uncontrolled immune suppression.
• Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, …) in the target knee within 90 days from randomisation.
• Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
• BMI<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns).
• Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
• Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
• Patients with psychosocial problems as determined by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 2 центра

• Dijklander Ziekenhuis — Hoorn
• Bravis Ziekenhuis — Roosendaal

Публикации

• Wit PR, Beek RV, Schokker M, Wensing C, Hollmann MW, Kallewaard JW, Oei G; RADIOPHENOL collaborators; Collaborative group name. Genicular nerve radiofrequency ablation, phenol neurolysis or conservative medical management in patients with knee osteoarthritis: protocol for the RADIOPHENOL randomised controlled multicentre trial with three parallel groups. BMJ Open. 2025 Jul 6;15(7):e094576. doi: 10 PMID 40623740

Идентификаторы

NCT: NCT06094660 · DOC 045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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