- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07781059
The Predictive Value of Ultrasonographic Quadriceps Muscle Parameters for Genicular Nerve Block Outcomes in Knee Osteoarthritis
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Pendik
-
Istanbul, Pendik, Tyrkia (Türkiye), 34899
- Marmara University Pendik Training and Research Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Patients With Chronic Knee Osteoarthritis Undergoing Ultrasound- Guided 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Baseline Vastus Lateralis Muscle Thickness
Tidsramme: Baseline
|
Vastus lateralis muscle thickness assessed by ultrasound and recorded in millimeters (mm).
|
Baseline
|
|
Baseline Vastus Lateralis Pennation Angle
Tidsramme: Baseline
|
Description: Vastus lateralis pennation angle assessed by ultrasound and recorded in degrees (°).
|
Baseline
|
|
Baseline Vastus Lateralis Fascicle Length
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09.2019.1051
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