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Nerve to Vastus Medialis Branches in Chronic Knee Pain

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

66

Kontakter og lokationer

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Studiesteder

Deltagelseskriterier

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Berettigelseskriterier

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  • Voksen
  • Ældre voksen

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Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Procedure: Conventional Genicular Nerve Radiofrequency
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.
Andre navne:
  • 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.
Procedure: Conventional Genicular Nerve Radiofrequency
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.
Andre navne:
  • Genicular nerve radiofrequency ablation
Procedure: Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency of the Distal Sensory Branches of the Nerve to Vastus Medialis
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.
Andre navne:
  • Genicular nerve RF plus nerve to vastus medialis PRF

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Visual Analog Scale Pain Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in WOMAC Score
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Diskapi Teaching and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. maj 2026

Primær færdiggørelse (Anslået)

20. august 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Geniculer RF&VM PRF

Plan for individuelle deltagerdata (IPD)

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INGEN

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