Osteoarthritis, KneeNCT04660071
Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Hacettepe University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- ultrasonographic Assessment, and Echo intensity Measurements
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Sep 2020to 24 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- ultrasonographic Assessment,, Echo intensity Measurements
- Keywords
- Reliability,Echo intensity,Knee Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic Assessment,Other
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 MeasurementsOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Thirty minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start18 Sep 2020
- Primary completion24 Nov 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MERVE KARAPINAR, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660071
- Sponsor's protocol ID
- 271
- Status last verified
- Dec 2020
- First submitted
- 24 Nov 2020
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis: Reliability of Echo Intensity Measurement
- ClinicalTrials.gov ID
- NCT04660071
- Acronym / sponsor ID
- 271
- Conditions
- Osteoarthritis, Knee
- Keywords
- Reliability,Echo intensity,Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 24 Nov 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | – |
| Echo intensity MeasurementsAll 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). | Other | – |
Primary outcome
Muscle Echogenicity Assessment ( Physiological parameter)
Time frame: Thirty minute
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Echogenicity Assessment ( Physiological parameter) (time frame: Thirty minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.