Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Knee Osteoarthritis (STAR-GNB)

14. juli 2026 opdateret af: Gaziosmanpasa Research and Education Hospital

Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Patients With Knee Osteoarthritis Undergoing Genicular Nerve Block: A Prospective Observational Study

Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability. Although genicular nerve block (GNB) is an effective treatment for many patients, treatment response varies considerably. Identifying imaging biomarkers that predict clinical response may improve patient selection and optimize treatment outcomes.

This prospective observational study aims to evaluate whether the Sonographic Thigh Adjustment Ratio (STAR), calculated as anterior quadriceps muscle thickness divided by body mass index (BMI), and subcutaneous fat thickness are associated with pain relief following genicular nerve block in patients with symptomatic knee osteoarthritis. Ultrasound measurements will be obtained before the procedure, and clinical outcomes will be assessed during follow-up. The primary objective is to determine whether sonographic muscle parameters can predict treatment response after GNB.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Knee osteoarthritis is one of the most common musculoskeletal disorders worldwide and is frequently associated with chronic pain, impaired mobility, and reduced quality of life. Genicular nerve block has become an established minimally invasive treatment for patients with persistent pain despite conservative management. However, substantial variability exists in treatment response, highlighting the need for reliable predictors of clinical success.

Recent studies have suggested that ultrasound-derived muscle measurements may provide objective information regarding muscle quality and sarcopenia. The Sonographic Thigh Adjustment Ratio (STAR), defined as anterior quadriceps muscle thickness normalized to body mass index (BMI), has been proposed as an ultrasound-based indicator of muscle mass. Nevertheless, its potential role in predicting the response to interventional pain procedures has not been investigated.

This prospective observational cohort study will enroll patients with symptomatic knee osteoarthritis who undergo ultrasound-guided genicular nerve block as part of routine clinical care. Before the procedure, ultrasound measurements of anterior quadriceps muscle thickness and subcutaneous fat thickness will be obtained. STAR will be calculated by dividing anterior quadriceps muscle thickness by BMI. Clinical outcomes will be assessed using validated pain and functional outcome measures during follow-up.

The primary objective is to evaluate whether STAR predicts treatment response after genicular nerve block. Secondary objectives include investigating the predictive value of quadriceps muscle thickness and subcutaneous fat thickness individually and exploring their relationship with pain reduction and functional improvement.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Istanbul, Tyrkiet (Türkiye), 34255
        • Rekruttering
        • University of Health Sciences Gaziosmanpaşa Physical Therapy and Rehabilitation Training and Research Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Tuğçe Yavuz Mollavelioğlu, Medical Doctor

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults with symptomatic bilateral Kellgren-Lawrence grade 3-4 knee osteoarthritis referred from the Department of Physical Medicine and Rehabilitation to the Pain Medicine Clinic for ultrasound-guided genicular nerve block after failure of conservative treatment. Consecutive eligible patients meeting the inclusion criteria will be enrolled prospectively.

Beskrivelse

Inclusion Criteria:

  • Age ≥45 years.
  • Symptomatic bilateral knee osteoarthritis with Kellgren-Lawrence grade 3 or 4.
  • Visual Analog Scale (VAS) pain score ≥4 at rest or during movement.
  • Scheduled to undergo first ultrasound-guided genicular nerve block.
  • No intra-articular knee injection within the previous 3 months.
  • Considered unsuitable for or awaiting total knee arthroplasty.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Inflammatory arthritis, rheumatoid arthritis, or crystal arthropathy.
  • Previous knee surgery or knee prosthesis.
  • Active local or systemic infection.
  • Anticoagulant therapy or bleeding disorders.
  • Contraindication to corticosteroids (including uncontrolled diabetes mellitus).
  • Allergy to study medications.
  • Neurological disorders causing neuropathic knee pain.
  • Dementia or inability to complete study assessments.
  • Additional interventional procedures or surgery during follow-up.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients With Knee Osteoarthritis Undergoing Genicular Nerve Block
Adults with symptomatic Kellgren-Lawrence grade 3-4 knee osteoarthritis undergoing ultrasound-guided genicular nerve block as part of routine clinical care. Participants undergo baseline ultrasonographic assessment of quadriceps muscle thickness, subcutaneous fat thickness, and calculation of the Sonographic Thigh Adjustment Ratio (STAR), followed by clinical follow-up at 1 and 3 months.
Procedure: Ultrasound-Guided Genicular Nerve Block
Ultrasound-guided genicular nerve block was performed as part of routine clinical care in patients with symptomatic knee osteoarthritis. The superomedial, superolateral, and inferomedial genicular nerves were targeted using a standardized ultrasound-guided technique. A standardized injectate consisting of bupivacaine, dexamethasone, and normal saline was administered to each target nerve. The procedure was performed by an experienced pain physician using the same protocol for all participants.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Response at 1 Month Following Genicular Nerve Block
Tidsramme: 1 month
Treatment response will be defined as a ≥50% reduction in Visual Analog Scale (VAS) pain score from baseline at 1 month after ultrasound-guided genicular nerve block. The predictive value of baseline Sonographic Thigh Adjustment Ratio (STAR) for 1-month treatment response will be evaluated.
1 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Responder Pattern After Genicular Nerve Block
Tidsramme: 1 month, and 3 months
Participants will be classified according to pain response pattern after genicular nerve block: non-response, defined as less than 50% reduction in VAS pain score at 1 month; transient response, defined as at least 50% reduction at 1 month but less than 50% reduction at 3 months; and sustained response, defined as at least 50% reduction at both 1 and 3 months. The association between baseline STAR and responder pattern will be evaluated.
1 month, and 3 months
WOMAC Score
Tidsramme: Baseline, 1 month, and 3 months
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Baseline, 1 month, and 3 months
Five Times Sit-to-Stand Test
Tidsramme: Baseline, 1 month, and 3 months
Change in functional performance assessed using the Five Times Sit-to-Stand (5xSTS) test.
Baseline, 1 month, and 3 months
Change in Pain Intensity
Tidsramme: Baseline, 1 month, and 3 months
Change in Visual Analog Scale (VAS) pain score from baseline after ultrasound-guided genicular nerve block.
Baseline, 1 month, and 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Gaziosmanpasa Research and Education Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. maj 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MEDIPOL-EC-845-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The investigators have not yet made a final decision regarding individual participant data (IPD) sharing. Data sharing will be considered after study completion in accordance with institutional policies, ethical requirements, and applicable data protection regulations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Knæ slidgigt

Kliniske forsøg med Ultrasound-Guided Genicular Nerve Block

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Russia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner