Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Nerve to Vastus Medialis Branches in Chronic Knee Pain

8 de julho de 2026 atualizado por: Damla Yürük, Diskapi Teaching and Research Hospital

Chronic Knee Pain Beyond the Genicular Nerves: The Role of Distal Sensory Branches of the Nerve to Vastus Medialis

This observational cohort study aims to evaluate the clinical effect of adding ultrasound-guided pulsed radiofrequency treatment of the distal superficial and deep sensory branches of the nerve to vastus medialis to conventional genicular nerve radiofrequency treatment in patients with chronic knee pain due to knee osteoarthritis.

Adult patients aged 45-80 years with clinically and radiologically confirmed knee osteoarthritis and chronic knee pain lasting at least 3 months despite conservative treatment will be included. Patients will be followed according to routine clinical practice. Two cohorts will be evaluated: patients treated with conventional genicular nerve radiofrequency alone and patients treated with conventional genicular nerve radiofrequency plus pulsed radiofrequency of the distal sensory branches of the nerve to vastus medialis.

Pain intensity will be assessed using the Visual Analog Scale, and functional status will be evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index. Assessments will be performed before the procedure, at 1 month, and at 3 months after treatment. Adverse events recorded in patient files will also be evaluated.

Visão geral do estudo

Descrição detalhada

Chronic knee pain related to knee osteoarthritis is mediated by a complex sensory innervation network. Although genicular nerves are commonly targeted in radiofrequency procedures for knee osteoarthritis pain, recent anatomical and ultrasound-based studies suggest that additional sensory branches may contribute to medial knee joint pain. The distal sensory branches of the nerve to vastus medialis have been described as contributors to the sensory innervation of the medial knee joint capsule.

In routine clinical practice, patients with chronic knee pain due to knee osteoarthritis may undergo ultrasound-guided conventional radiofrequency treatment of the genicular nerves. In some patients, pulsed radiofrequency treatment targeting the distal superficial and deep sensory branches of the nerve to vastus medialis may also be added. This study will compare clinical outcomes between these two routinely treated cohorts.

The study will include adult patients aged 45-80 years with knee osteoarthritis confirmed clinically and radiologically, Kellgren-Lawrence grade II-IV, chronic knee pain lasting at least 3 months, and insufficient response to conservative treatments. The primary outcome will be the change in pain intensity measured by the Visual Analog Scale from baseline to follow-up. Functional outcomes will be assessed using the WOMAC score. Evaluations will be performed at baseline, 1 month, and 3 months after the procedure. Safety outcomes will include procedure-related adverse events such as hematoma, infection, increased neuropathic pain, or transient motor impairment.

No additional intervention will be performed for research purposes, and treatment allocation will not be determined by the investigators.

Tipo de estudo

Observacional

Inscrição (Estimado)

66

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population will consist of adult patients aged 45 to 80 years with clinically and radiologically confirmed knee osteoarthritis and chronic knee pain lasting at least 3 months despite conservative treatment. Eligible patients will be those who are evaluated in the Algology Clinic and undergo ultrasound-guided genicular nerve radiofrequency treatment, with or without additional pulsed radiofrequency treatment targeting the distal sensory branches of the nerve to vastus medialis, as part of routine clinical practice. Patients will be included after providing written informed consent and will be followed for pain and functional outcomes at baseline, 1 month, and 3 months after the procedure.

Descrição

Inclusion Criteria:

Age between 45 and 80 years Clinical and radiological diagnosis of knee osteoarthritis Kellgren-Lawrence grade II-IV knee osteoarthritis Chronic knee pain lasting at least 3 months Insufficient response to conservative treatments such as NSAIDs, physical therapy, or exercise programs Baseline Visual Analog Scale pain score ≥5 No coagulation disorder or active infection that would contraindicate the procedure Written informed consent provided by the participant

Exclusion Criteria:

Knee pain primarily caused by conditions other than osteoarthritis, including inflammatory arthritis, septic arthritis, tumor-related causes, or infectious causes Previous total knee arthroplasty or knee prosthesis surgery in the affected knee Radiofrequency or neurolytic procedure around the affected knee within the last 6 months Severe knee instability, advanced deformity, or history of acute trauma Active infection, skin lesion, or ulceration at the procedure site Uncontrolled systemic disease such as advanced heart failure or uncontrolled diabetes Bleeding diathesis or inability to discontinue anticoagulant therapy for an appropriate duration Pregnancy or lactation Cognitive impairment, inability to cooperate, or inability to comply with follow-up visits

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Conventional Genicular Nerve Radiofrequency
Patients with chronic knee pain due to knee osteoarthritis who received ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves as part of routine clinical practice.
Ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves will be performed as part of routine clinical practice in patients with chronic knee pain due to knee osteoarthritis. Pain and functional outcomes will be evaluated using the Visual Analog Scale and WOMAC scores at baseline, 1 month, and 3 months after the procedure.
Outros nomes:
  • Genicular nerve radiofrequency ablation
Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency Nerves Vastus Medialis
Patients with chronic knee pain due to knee osteoarthritis who received ultrasound-guided conventional genicular nerve radiofrequency treatment plus pulsed radiofrequency treatment targeting the distal superficial and deep sensory branches of the nervus vastus medialis as part of routine clinical practice.
Ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves will be performed as part of routine clinical practice in patients with chronic knee pain due to knee osteoarthritis. Pain and functional outcomes will be evaluated using the Visual Analog Scale and WOMAC scores at baseline, 1 month, and 3 months after the procedure.
Outros nomes:
  • Genicular nerve radiofrequency ablation
Ultrasound-guided conventional radiofrequency treatment targeting the genicular nerves will be combined with pulsed radiofrequency treatment of the distal superficial and deep sensory branches of the nerve to vastus medialis. This combined approach will be performed as part of routine clinical practice in patients with chronic knee pain due to knee osteoarthritis. Pain intensity and functional status will be assessed using the Visual Analog Scale and WOMAC scores at baseline, 1 month, and 3 months after the procedure.
Outros nomes:
  • Genicular nerve RF plus nerve to vastus medialis PRF

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Visual Analog Scale Pain Score
Prazo: Baseline, 1 month, and 3 months after the procedure
Change in knee pain intensity measured using the Visual Analog Scale. The score ranges from 0 to 10, with higher scores indicating more severe pain.
Baseline, 1 month, and 3 months after the procedure

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in WOMAC Score
Prazo: Baseline, 1 month, and 3 months after the procedure
Change in knee osteoarthritis-related pain, stiffness, and physical function assessed using the Western Ontario and McMaster Universities Osteoarthritis Index. Higher scores indicate worse symptoms and functional impairment.
Baseline, 1 month, and 3 months after the procedure

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de maio de 2026

Conclusão Primária (Estimado)

20 de agosto de 2027

Conclusão do estudo (Estimado)

1 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de julho de 2026

Primeira postagem (Real)

14 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Geniculer RF&VM PRF

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Osteoartrite do joelho

Ensaios clínicos em Conventional Genicular Nerve Radiofrequency

3
Se inscrever