- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07314840
Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis
Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis: A Cross-Sectional Study
Lateral epicondylitis (LE) is the tendinopathy of the common extensor tendon. Although exact etiology remains unclear, it is believed to be caused by overuse.
Even though, genetics factor related to tendinopathies were defined accompanying tendinopathies in patients with LE is yet to be studied.
Madrid sonographic enthesitis index (MASEI) is an ultrasound based scoring system, developed for the evaluation of the enthesitis. Initially developed for ankylosing spondylitis, its usage has also become widespread in other musculoskeletal diseases.
The aim of this study is to calculate the MASEI score in patients diagnosed with LE, and compare it to healthy volunteers.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Arda Can Kasap, MD
- Phone Number: 905384590119
- Email: drardakasap@gmail.com
Study Locations
-
-
Maltepe
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Istanbul, Maltepe, Turkey (Türkiye), 34844
- Recruiting
- Marmara University
-
Contact:
- Arda Can Kasap, MD
- Phone Number: 905384590119
- Email: drardakasap@gmail.com
-
Sub-Investigator:
- Arda Can Kasap, MD
-
Principal Investigator:
- İlker Yağcı, Prof. M.D.
-
Sub-Investigator:
- Naime Evrim Karadağ Saygı, Prof. M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients presented to the outpatient clinic of Physical Medicine and Rehabilitation of Marmara University with elbow pain and diagnosed with lateral epicondylitis will be informed about the study. Willing patients will be enrolled after written consent is taken.
Control group will be chosen with volunteers, which have similar demographic characteristics.
Description
Inclusion Criteria:
- Tenderness with palpation at the lateral epicondyle
- Pain aggravated with resisted wrist extension
Exclusion Criteria:
- History of rheumatologic diseases
- History of elbow, knee or ankle surgery
- History of corticosteroid injections on elbow, knee or ankle
- History of peripheral neuropathy
- Acute trauma
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Lateral Epicondylitis
Patients with lateral epicondylitis will be included in this group.
|
Patients will be evaluated with ultrasound at 6 different locations on each side, for total of 12 locations.
These will be insertion points of triceps brachii tendon, quadriceps tendon, proximal and distal patellar tendons, achilles tendon and the plantar fascia.
Evaluation parameters are the structure and thickness of the tendon, the presence of calcifications or enthesophytes, erosions in the bone, regional bursitis, and the presence of power-Doppler signal in the entheses.
Other Names:
|
|
Control
Healthy volunteers with similar demographic characteristics will be enrolled to this group.
|
Patients will be evaluated with ultrasound at 6 different locations on each side, for total of 12 locations.
These will be insertion points of triceps brachii tendon, quadriceps tendon, proximal and distal patellar tendons, achilles tendon and the plantar fascia.
Evaluation parameters are the structure and thickness of the tendon, the presence of calcifications or enthesophytes, erosions in the bone, regional bursitis, and the presence of power-Doppler signal in the entheses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Madrid Sonographic Enthesitis Index
Time Frame: At enrollment
|
Patients will be evaluated with ultrasound at 6 different locations on each side, for total of 12 locations.
At each location; structure and thickness of the tendon, the presence of calcifications or enthesophytes, erosions in the bone, regional bursitis, and the presence of power-Doppler signal will be noted.
Each parameter has a point of its own.
Points obtained from each parameter will be added and total MASEI score (0-136) will be calculated.
Higher scores indicate the presence of enthesitis.
|
At enrollment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: İlker Yağcı, Prof. Dr., Acıbadem Ataşehir Hospital
Publications and helpful links
General Publications
- Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
- de Miguel E, Cobo T, Munoz-Fernandez S, Naredo E, Uson J, Acebes JC, Andreu JL, Martin-Mola E. Validity of enthesis ultrasound assessment in spondyloarthropathy. Ann Rheum Dis. 2009 Feb;68(2):169-74. doi: 10.1136/ard.2007.084251. Epub 2008 Apr 7.
- Ozsoy-Unubol T, Yagci I. Is ultrasonographic enthesitis evaluation helpful for diagnosis of non-radiographic axial spondyloarthritis? Rheumatol Int. 2018 Nov;38(11):2053-2061. doi: 10.1007/s00296-018-4164-4. Epub 2018 Oct 9.
- Okur SC, Dogan YP, Mert M, Aksu O, Burnaz O, Caglar NS. Ultrasonographic Evaluation of Lower Extremity Entheseal Sites in Diabetic Patients Using Glasgow Ultrasound Enthesitis Scoring System Score. J Med Ultrasound. 2017 Jul-Sep;25(3):150-156. doi: 10.1016/j.jmu.2017.03.011. Epub 2017 May 6.
- Karanasios S, Korakakis V, Moutzouri M, Drakonaki E, Koci K, Pantazopoulou V, Tsepis E, Gioftsos G. Diagnostic accuracy of examination tests for lateral elbow tendinopathy (LET) - A systematic review. J Hand Ther. 2022 Oct-Dec;35(4):541-551. doi: 10.1016/j.jht.2021.02.002. Epub 2021 Feb 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2025.25-0844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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