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

August 20, 2026 updated by: Marmara University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Pendik
      • Istanbul, Pendik, Turkey (Türkiye), 34899
        • Marmara University Pendik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 50 to 80 years with unilateral chronic knee pain due to clinically and radiologically confirmed knee osteoarthritis. Participants had Kellgren-Lawrence grade 3 or 4 osteoarthritis, had not responded adequately to conservative treatments, and were already scheduled to undergo genicular nerve block as part of routine clinical care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block
Procedure: genicular nerve block
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline , 3 weeks, and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Baseline Vastus Lateralis Muscle Thickness
Time Frame: Baseline
Vastus lateralis muscle thickness assessed by ultrasound and recorded in millimeters (mm).
Baseline
Baseline Vastus Lateralis Pennation Angle
Time Frame: Baseline
Description: Vastus lateralis pennation angle assessed by ultrasound and recorded in degrees (°).
Baseline
Baseline Vastus Lateralis Fascicle Length
Time Frame: Baseline
Description: Vastus lateralis fascicle length assessed by ultrasound and recorded in millimeters (mm).
Baseline
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.
Baseline, 3 weeks, and 3 months after the procedure
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.
Baseline, 3 weeks, and 3 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 09.2019.1051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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