Lateral EpicondylitisNCT07314840
Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis
An observational study of Lateral Epicondylitis and Lateral Elbow Tendinopathy (Tennis Elbow), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis, Lateral Elbow Tendinopathy (Tennis Elbow)
- What is being tested?
- Madrid Sonographic Enthesitis Index
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Tenderness with palpation at the lateral epicondyle
- Pain aggravated with resisted wrist extension
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, Maltepe, 34844
Arda Can Kasap, MD, 905384590119, drardakasap@gmail.com
Arda Can Kasap, MD
About this study
Official title: 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.
- Being tested
- Madrid Sonographic Enthesitis Index
- Keywords
- Lateral Epicondylitis, Lateral Elbow Tendinopathy, Tennis Elbow, Enthesitis, Madrid Sonographic Enthesitis Index, MASEI
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Madrid Sonographic Enthesitis IndexDiagnostic test
Also called MASEI
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.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Epicondylitis | Patients with lateral epicondylitis will be included in this group. Receives: Diagnostic Test: Madrid Sonographic Enthesitis Index | |
| Control | Healthy volunteers with similar demographic characteristics will be enrolled to this group. Receives: Diagnostic Test: Madrid Sonographic Enthesitis Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Madrid Sonographic Enthesitis Index
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Oct 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Yağcı, Marmara University
- Investigators
- İlker Yağcı, Prof. Dr., Principal investigator, Acıbadem Ataşehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314840
- Sponsor's protocol ID
- 09.2025.25-0844
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to legal restrictions, all data will be anonymized. Individual participant data won't be shared to third parties.
Publications
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.
PubMed 30302556de 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.
PubMed 18390909Okur 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.
PubMed 30065480Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
PubMed 33123709Karanasios 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.
PubMed 33814224
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07314840
- Acronym / sponsor ID
- 09.2025.25-0844
- Keywords
- Lateral Epicondylitis, Lateral Elbow Tendinopathy, Tennis Elbow, Enthesitis, Madrid Sonographic Enthesitis Index, MASEI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 2 Jan 2026 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Epicondylitis | – | Diagnostic Test: Madrid Sonographic Enthesitis IndexPatients with lateral epicondylitis will be included in this group. |
| Control | – | Diagnostic Test: Madrid Sonographic Enthesitis IndexHealthy volunteers with similar demographic characteristics will be enrolled to this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Tenderness with palpation at the lateral epicondyle
- Pain aggravated with resisted wrist extension
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Madrid Sonographic Enthesitis IndexAlso: MASEIPatients 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. | Diagnostic test | Control, Lateral Epicondylitis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 30302556Ozsoy-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.
- Background: PubMed 18390909de 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.
- Background: PubMed 30065480Okur 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.
- Background: PubMed 33123709Johns N, Shridhar V. Lateral epicondylitis: Current concepts. Aust J Gen Pract. 2020 Nov;49(11):707-709. doi: 10.31128/AJGP-07-20-5519.
- Background: PubMed 33814224Karanasios 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.
- Individual participant dataSharing planned: No. Due to legal restrictions, all data will be anonymized. Individual participant data won't be shared to third parties.
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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.
İlker Yağcı, Prof. Dr. principal investigator
Acıbadem Ataşehir Hospital
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 Lateral Epicondylitis and Lateral Elbow Tendinopathy (Tennis Elbow), run by Marmara 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arda Can Kasap, MD (905384590119, drardakasap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Madrid Sonographic Enthesitis Index (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314840, which also lists 5 linked publications.
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 2 Jan 2026.