NCT04660071

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

November 24, 2020

Last Update Submit

December 2, 2020

Conditions

Keywords

Reliability,Echo intensity,Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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).

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).

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merve Karapinar

Isparta, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assisstant, Physiotherapist

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 9, 2020

Study Start

September 18, 2020

Primary Completion

November 24, 2020

Study Completion

November 24, 2020

Last Updated

December 9, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations