Nerve to Vastus Medialis Branches in Chronic Knee Pain

NCT07703293 | Recruiting DMC

• 1 other identifier: Geniculer RF&VM PRF
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Chronic Knee Pain

Keywords

Genicular nerve; Nervus vastus medialis; Chronic knee pain

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale Pain Score

  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

Secondary Outcomes (1)

• Change in WOMAC Score

  Baseline, 1 month, and 3 months after the procedure

Study Arms (2)

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

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

Interventions

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.

Also known as: Genicular nerve radiofrequency ablation

Conventional Genicular Nerve Radiofrequency; Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency Nerves Vastus Medialis

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.

Also known as: Genicular nerve RF plus nerve to vastus medialis PRF

Conventional Genicular Nerve Radiofrequency Plus Pulsed Radiofrequency Nerves Vastus Medialis

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ayse Betul Acar

Ankara, 06500, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Saena S, Sukhonthamarn K, Kosuwon W, Apinyankul R, Witayakom W. Anatomical presentation of the nerve to vastus medialis within the adductor canal and femoral nerve branch insertions into thigh muscles: a cadaveric study. Surg Radiol Anat. 2025 Oct 31;47(1):250. doi: 10.1007/s00276-025-03763-0.

  PMID: 41174247 BACKGROUND

• Orduna-Valls J, Ferreira-Silva N, Acevedo C, Cunat T, Araujo-Cernuda R, Vallejo R, Ribeiro-da-Silva T, Pena I, Ferreira-Dos-Santos G. The nerve to vastus medialis as a target for treating chronic medial knee joint pain: an ultrasound-based anatomical localization study in healthy subjects. Pain Med. 2026 Feb 1;27(2):170-176. doi: 10.1093/pm/pnaf111.

  PMID: 40828883 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): August 20, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)