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NCT Number: NCT07781059

The Predictive Value of Ultrasonographic Quadriceps Muscle Parameters for Genicular Nerve Block Outcomes in Knee Osteoarthritis

The goal of this observational study is to learn whether thigh muscle structure can help predict pain relief after a genicular nerve block in people with knee osteoarthritis. A genicular nerve block is an injection used to reduce pain signals from the knee.

The main questions are:

* Are muscle thickness, fiber length, and fiber angle linked to pain relief after the procedure? * Are these muscle measurements linked to changes in physical function and quality of life?

Participants are adults aged 50 to 80 with long-term pain from osteoarthritis in one knee. They are already scheduled to receive a genicular nerve block as part of their regular medical care. The study does not assign participants to receive this procedure.

Before the procedure, researchers will use ultrasound to measure the vastus lateralis muscle in the thigh. Participants will also answer questions about pain, daily function, and quality of life. Researchers will repeat these assessments after 1 hour, 3 weeks, and 3 months. Pain relief will be considered successful when pain is at least half as severe as it was before the procedure.

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Key information

Conditions

Knee Arthritis Osteoarthritis Agnosia Chronic Knee Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 50 and 80 years
  • Unilateral symptomatic knee osteoarthritis
  • Chronic knee pain for at least 3 months
  • Clinical and radiographic confirmation of knee osteoarthritis
  • Kellgren-Lawrence grade 3 or 4 knee osteoarthritis
  • Inadequate clinical response despite analgesic therapy and physical therapy
  • Clinical indication for genicular nerve block

Exclusion criteria

  • History of surgery involving the knee region
  • Bilateral symptomatic knee osteoarthritis
  • Intra-articular knee injection within the previous 3 months
  • Systemic disease that could affect study assessments
  • Systemic or local infection
  • Coagulation disorder
  • Failure to provide written informed consent

Treatment and study plan

Genicular nerve Block

Procedure

Ultrasound-guided genicular nerve block targeting the superomedial, superolateral, and inferomedial genicular nerves was performed as part of routine clinical management for chronic knee osteoarthritis.

Primary outcomes

  1. Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS)

    Time frame: Baseline , 3 weeks, and 3 months

    Pain intensity will be assessed using an 11-point Numeric Rating Scale ranging from 0 (no pain) to 10 (worst imaginable pain). Changes from baseline will be evaluated following ultrasound-guided genicular nerve block. Lower scores indicate lower pain intensity.

Secondary outcomes

  1. Baseline Vastus Lateralis Muscle Thickness

    Time frame: Baseline

    Vastus lateralis muscle thickness assessed by ultrasound and recorded in millimeters (mm).

  2. Baseline Vastus Lateralis Pennation Angle

    Time frame: Baseline

    Description: Vastus lateralis pennation angle assessed by ultrasound and recorded in degrees (°).

  3. Baseline Vastus Lateralis Fascicle Length

    Time frame: Baseline

    Description: Vastus lateralis fascicle length assessed by ultrasound and recorded in millimeters (mm).

  4. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

    Time frame: Baseline, 3 weeks, and 3 months after the procedure

    Description: Pain, stiffness, and physical function related to knee osteoarthritis will be assessed using the 24-item WOMAC questionnaire. The total score ranges from 0 to 96, with higher scores indicating greater pain, stiffness, and functional impairment. Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.

  5. Change in Health-Related Quality of Life Assessed by the EQ-5D

    Time frame: Baseline, 3 weeks, and 3 months after the procedure

    Description: Health-related quality of life will be assessed using the EQ-5D questionnaire. Responses will be converted into an EQ-5D index score, where higher scores indicate better health status. A score of 1 represents full health, 0 represents a health state equivalent to death, and negative scores represent health states considered worse than death. Changes from baseline will be evaluated following ultrasound-guided genicular nerve block.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Role of Quadriceps Muscle Architecture Parameters in Predicting the Success of Genicular Nerve Block in Patients With Chronic Knee Osteoarthritis Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 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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