NCT07781059

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

August 17, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

knee osteoartritisgenicular nerve blockquadriceps muscle architectureultrasound -guidedpain managementWOMACEQ-5DNumeric Rating Scale

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (5)

  • Baseline Vastus Lateralis Muscle Thickness

    Baseline

  • Baseline Vastus Lateralis Pennation Angle

    Baseline

  • Baseline Vastus Lateralis Fascicle Length

    Baseline

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

    Baseline, 3 weeks, and 3 months after the procedure

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

    Baseline, 3 weeks, and 3 months after the procedure

Study Arms (1)

Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block

Procedure: genicular nerve block

Interventions

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.

Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided Genicular Nerve Block

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 24, 2026

Study Start

June 1, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

August 24, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations