- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04660071
Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis
December 2, 2020 updated by: MERVE KARAPINAR, Hacettepe University
Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis: Reliability of Echo Intensity Measurement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
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
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Isparta, Turkey
- Merve Karapinar
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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
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
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.
Description
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 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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Muscle Echogenicity Assessment ( Physiological parameter)
Time Frame: Thirty minute
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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.
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Thirty minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 18, 2020
Primary Completion (Actual)
November 24, 2020
Study Completion (Actual)
November 24, 2020
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 9, 2020
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 2, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271
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
product manufactured in and exported from the U.S.
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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