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NCT Number: NCT07703293

Nerve to Vastus Medialis Branches in Chronic Knee Pain

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional Genicular Nerve Radiofrequency

Procedure

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.

Other names: Genicular nerve radiofrequency ablation

Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency of the Distal Sensory Branches of the Nerve to Vastus Medialis

Procedure

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.

Other names: Genicular nerve RF plus nerve to vastus medialis PRF

Primary outcomes

  1. Change in Visual Analog Scale Pain Score

    Time frame: 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.

Secondary outcomes

  1. Change in WOMAC Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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