Lateral Elbow Tendinopathy (Tennis Elbow)NCT07347873
Diagnostic Accuracy of the Clinical Tests and the Ultrasonography in Lateral Elbow Tendinopathy
An observational study of Lateral Elbow Tendinopathy (Tennis Elbow), run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Lateral elbow tendinopathy (LET) is the most common cause of elbow pain. Even though provocation tests such as Cozen's test, Mill's test or Maudsley test; musculoskeletal ultrasound or magnetic resonance imaging can be used for diagnosis, gold standard method is yet to be determined. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Elbow Tendinopathy (Tennis Elbow)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Oct 2025to 26 Mar 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
- Patients aged 18-60 with unilateral elbow pain
- Tenderness with palpation at the lateral epicondyle
- Pain triggered with pressure compared to the opposite lateral epicondyle with algometer.
Who cannot join
- History of rheumatologic diseases
- History of e corticosteroid injections on lateral epicondyle
- History of elbow surgery or infection
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, M.D., 902166254545, drardakasap@gmail.com
Arda Can Kasap, M.D.
About this study
Official title: Diagnostic Accuracy of the Clinical Tests and the Musculoskeletal Ultrasonography in Lateral Elbow Tendinopathy
Lateral elbow tendinopathy (LET) is the most common cause of elbow pain. Even though provocation tests such as Cozen's test, Mill's test or Maudsley test; musculoskeletal ultrasound or magnetic resonance imaging can be used for diagnosis, gold standard method is yet to be determined. Purpose of this study is to determine the sensitivity and specificity of clinical tests and ultrasonography in diagnosis of LET.
- Keywords
- Elbow pain, Lateral epicondylitis, Cozen, Elastography
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lateral elbow tendinopathy | Patients with lateral epicondylitis will be included in this group. | |
| Control | Healthy volunteers with similar demographic characteristics will be enrolled to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elastography
Both shear wave and strain elastography will be applied. Stiffness and shear wave velocity will be calculated on shear wave elastography and strain ratio will be calculated on strain elastography.
Measured: At enrollment
Secondary outcomes (7)
Musculoskeletal ultrasound
Sonographic evaluation will begin with gray scale examination. Swelling, cortical irregularity, hypoechogenicity, calcification, tear common extensor tendon thickness will be assessed. Power doppler will be evaluated between the superficial fibers of the common extensor tendon, the bone surface, the insertion point of the common extensor tendon and the humeroradial joint. Doppler activity will be graded based in a 0.5-cm longitudinal part of the tendon with the maximal Doppler activity (the region of interest-ROI). The 5-point grading will be as follows. Grade 0: No activity, Grade 1: Single vessel, Grade 2: Doppler activity in 0-25% of the ROI, Grade 3: Doppler activity in 25-50% of the ROI, Grade 4: Doppler activity in >50 of ROI. Lastly elastography will be used.
Measured: At enrollment
Cozen's test
Resisted wrist extension will be performed while patient is sitting and elbow on extension. Cozen's test will be applied to both extremities. Pain felt on the lateral epicondyle during provocation indicates a positive test result.
Measured: At enrollment
Maudsley's Test
Resisted third finger extension will be performed while patient is sitting and elbow on 90 degrees flexion. Maudsley's test will be applied to both extremities. Pain felt on the lateral epicondyle during provocation indicates a positive test result.
Measured: At enrollment
Mill's test
Maximal wrist flexion will be performed while patient is sitting, elbow on extension and forearm pronation. Mill's test will be applied to both extremities. Pain felt on the lateral epicondyle during provocation indicates a positive test result.
Measured: At enrollment
Hand Grip Strength
Both painless and maximum grip strength will be examined using Jamar's hand dynamometer.
Measured: At enrollment
Algometer
Force will be applied to lateral epicondyle using an algometer.
Measured: At enrollment
Patient Rated Tennis Elbow Evaluation
Patient Rated Tennis Elbow Evaluation will be used to assess pain and functional status in patients diagnosed with LET.
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 posted16 Jan 2026
- Study start17 Oct 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lateral Elbow Tendinopathy (Tennis Elbow)Studies 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
- 100 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. M.D., Principal investigator, Acıbadem Ataşehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347873
- Sponsor's protocol ID
- 09.2025.25-0880
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 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
Krogh TP, Fredberg U, Ammitzboll C, Ellingsen T. Clinical Value of Ultrasonographic Assessment in Lateral Epicondylitis Versus Asymptomatic Healthy Controls. Am J Sports Med. 2020 Jul;48(8):1873-1883. doi: 10.1177/0363546520921949. Epub 2020 Jun 2.
PubMed 32484714Hong S, Hahn S, Yi J, Park EJ, Bang JY. Comparing the clinical application of strain elastography and shear wave elastography for the evaluation of lateral epicondylitis. J Clin Ultrasound. 2023 Jan;51(1):123-130. doi: 10.1002/jcu.23356. Epub 2022 Sep 28.
PubMed 36169174Karanasios 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the Clinical Tests and the Musculoskeletal Ultrasonography in Lateral Elbow Tendinopathy
- ClinicalTrials.gov ID
- NCT07347873
- Acronym / sponsor ID
- 09.2025.25-0880
- Keywords
- Elbow pain, Lateral epicondylitis, Cozen, Elastography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 16 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 elbow tendinopathy (LET) is the most common cause of elbow pain. Even though provocation tests such as Cozen's test, Mill's test or Maudsley test; musculoskeletal ultrasound or magnetic resonance imaging can be used for diagnosis, gold standard method is yet to be determined. Purpose of this study is to determine the sensitivity and specificity of clinical tests and ultrasonography in diagnosis of LET.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral elbow tendinopathy | – | –Patients with lateral epicondylitis will be included in this group. |
| Control | – | –Healthy 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 (3 listed)
- Patients aged 18-60 with unilateral elbow pain
- Tenderness with palpation at the lateral epicondyle
- Pain triggered with pressure compared to the opposite lateral epicondyle with algometer.
Key exclusion criteria (3 listed)
- History of rheumatologic diseases
- History of e corticosteroid injections on lateral epicondyle
- History of elbow surgery or infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Elastography
Time frame: At enrollment
Both shear wave and strain elastography will be applied. Stiffness and shear wave velocity will be calculated on shear wave elastography and strain ratio will be calculated on strain elastography.
7 secondary outcomes
Musculoskeletal ultrasound
Time frame: At enrollment
Cozen's test
Time frame: At enrollment
Maudsley's Test
Time frame: At enrollment
Mill's test
Time frame: At enrollment
Hand Grip Strength
Time frame: At enrollment
Algometer
Time frame: At enrollment
Patient Rated Tennis Elbow Evaluation
Time frame: At enrollment
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 16 Jan 2026.
- Background: PubMed 32484714Krogh TP, Fredberg U, Ammitzboll C, Ellingsen T. Clinical Value of Ultrasonographic Assessment in Lateral Epicondylitis Versus Asymptomatic Healthy Controls. Am J Sports Med. 2020 Jul;48(8):1873-1883. doi: 10.1177/0363546520921949. Epub 2020 Jun 2.
- Background: PubMed 36169174Hong S, Hahn S, Yi J, Park EJ, Bang JY. Comparing the clinical application of strain elastography and shear wave elastography for the evaluation of lateral epicondylitis. J Clin Ultrasound. 2023 Jan;51(1):123-130. doi: 10.1002/jcu.23356. Epub 2022 Sep 28.
- 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. M.D. 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 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 3 inclusion and 3 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 16 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, M.D. (+902166254545, drardakasap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elastography (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 NCT07347873, which also lists 3 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 16 Jan 2026.