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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04660071
Other study ID # 271
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2020
Est. completion date November 24, 2020

Study information

Verified date December 2020
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Echo intensity (EI) assessment using ultrasonography helps monitoring disease-induced muscle quality changes. However, there are no study investigating the reliability of EI in patients with knee osteoarthritis (OA). The primary aim of the present study was to investigate the inter and intra-rater reliability of EI evaluation by grayscale histogram analysis of quadriceps femoris muscle in patients with knee OA. The second aim was to compare the mean grayscale values obtained using both the Free Hand Tool (FHT) and Rectangular Marquee Tool (RMT) methods in ImageJ. Thirty patients with knee OA were included in this cross-sectional study. The echogenicity measurements of the Rectus Femoris, Vastus Inter-medius, Vastus Lateralis and Vastus Medialis were performed by two different researchers. Reliability analysis of EI measurements were calculated with using intraclass correlation coefficient (ICC), standard error of measurement (SEM) and coefficient of variation (CV) and Bland and Altman plot analysis.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 24, 2020
Est. primary completion date November 24, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - Patients had tibiofemoral joint OA in at least one knee according to the American College of Rheumatology classification criteria with knee pain most days of the past month and osteophytes apparent on knee radiograph were included to the study Exclusion Criteria: - Patients were excluded if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis, diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ultrasonographic Assessment,
Ultrasound assessment was performed on rectus femoris (RF), vastus intermedius (VI), vastus medialis (VM) and vastus lateralis (VL) muscles using with an ultrasound-imaging device (Philips Medical Systems EPIQ 5 Release 5.0.2, Amsterdam).
Echo intensity Measurements
All images were analysed using the Image J software (Version 1.48v, National Institutes of Health, Bethesda, MD, USA) by two different analysers (five years and one-year of experience in US image analysis).

Locations

Country Name City State
Turkey Merve Karapinar Isparta

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Echogenicity Assessment ( Physiological parameter) Muscle echogenicity assessed by using ultrasound. Ultrasound assessment was performed on rectus femoris (RF), vastus intermedius (VI), vastus medialis (VM) and vastus lateralis (VL) muscles using with an ultrasound-imaging device (Philips Medical Systems EPIQ 5 Release 5.0.2, Amsterdam). Ultrasound Brightness mode (B-mode) with musculoskeletal scanning and a multi-frequency linear transducer (8-12 MHz, code: eL18-4) were used. For calculating echogenicity of muscles; all images obtained ultrasonography were analysed using the Image J software (Version 1.48v, National Institutes of Health, Bethesda, MD, USA) by two different analysers (five years and one-year of experience in US image analysis). The echogenicity results of the muscles performed by the two researchers recorded. Thirty minute
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