Lateral EpicondylitisNCT07127302
Correlation of Ultrasonographic Findings With Clinical Parameters in Patients With Lateral Epicondylitis
An observational study of Lateral Epicondylitis and Elastography, run by Ahmet Yesildag at 1 site in Turkey (Türkiye).
Trial summary
Evaluation and Clinical Correlation of Tendons Using Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients with Lateral Epicondylitis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lateral Epicondylitis, Elastography, Ultrasonographic Diagnosis
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2025to 19 Feb 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lateral epicondylitis or suspected lateral epicondylitis
Who may be able to join
- Lateral epicondylitis
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karamanoglu Mehmetbey Universty
Karaman, Merkez, 70110
About this study
Official title: Evaluation and Clinical Correlation of Tendons With Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients With Lateral Epicondylitis
Evaluation and Clinical Correlation of Tendons Using Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients with Lateral Epicondylitis.
Read the detailed description
The aim of the study was to perform tendon evaluation using different ultrasonography methods in patients with a diagnosis or prediagnosis of lateral epicondylitis and to determine the correlation between clinical findings and ultrasonographic findings. Hemodynamic and elastic properties of pathologic tendons will be examined using Power Doppler, Shear Wave Elastography (SWE), Microvascular Flow (MV-Flow) and B-Mode Ultrasonography methods.
In addition, clinical scoring of the cases will be compared with positive wrist extension tests agonist resistance (Cozen test) duration of pain in the lateral epicondyle region (weeks), VAS pain score at rest, VAS pain score during activity, VAS pain score during maximal grip, VAS pain score during maximal grip, and US findings to determine the ultrasonography technique with the highest clinical correlation.
In addition, the differences between pathologic tendons and normal tendons will be evaluated to determine the Doppler US findings with the highest diagnostic performance.
- Keywords
- Lateral epicondylitis, Ultrasonographic diagnosis, Doppler Ultrasound
- Medical subject headings
- Tennis Elbow
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between clinical scores and ultrasound findings in patients with lateral epicondylitis.
Correlation or logistic statistical analyses will be applied to reveal the relationship between ultrasound methods and clinical scores.
Measured: 3-5 months
Secondary outcomes (1)
Comparison of ultrasound findings in pathological tendons and normal tendons and demonstration of the diagnostic performance of ultrasound methods
Ultrasound measurements of normal and patological tendons will be compared by statistical methods such as indipendent T-test or Mann Whitney U.
Measured: 3-5 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start30 Sep 2025
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Yesildag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Yesildag, Karamanoğlu Mehmetbey University
- Investigators
- Ahmet Yeşildağ, Prof.Dr., Study director, Karamanoğlu Mehmetbey Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07127302
- Sponsor's protocol ID
- 19-2025/10
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26.
PubMed 18036844Zhou J, Yang DB, Wang J, Li HZ, Wang YC. Role of shear wave elastography in the evaluation of the treatment and prognosis of supraspinatus tendinitis. World J Clin Cases. 2020 Jul 26;8(14):2977-2987. doi: 10.12998/wjcc.v8.i14.2977.
PubMed 32775379Unal OF, BayramoGlu Z, AdaletlI I. Evaluation of Periarticular Soft Tissues in Patients With Juvenile Idiopathic Arthritis by Superb Microvascular Imaging and Shear Wave Elastography. Arch Rheumatol. 2020 Feb 7;35(2):264-273. doi: 10.46497/ArchRheumatol.2020.7640. eCollection 2020 Jun.
PubMed 32851377Gitto S, Messina C, Chianca V, Tuscano B, Lazzara A, Corazza A, Pedone L, Albano D, Sconfienza LM. Superb microvascular imaging (SMI) in the evaluation of musculoskeletal disorders: a systematic review. Radiol Med. 2020 May;125(5):481-490. doi: 10.1007/s11547-020-01141-x. Epub 2020 Feb 4.
PubMed 32020529Praet SFE, Ong JH, Purdam C, Welvaert M, Lovell G, Dixon L, Gaida JE, Anglim J, Manzanero S, Vlahovich N, Hughes D, Waddington G. Microvascular volume in symptomatic Achilles tendons is associated with VISA-A score. J Sci Med Sport. 2018 Dec;21(12):1185-1191. doi: 10.1016/j.jsams.2018.05.013. Epub 2018 May 15.
PubMed 29789266Arslan S, Karahan AY, Oncu F, Bakdik S, Durmaz MS, Tolu I. Diagnostic Performance of Superb Microvascular Imaging and Other Sonographic Modalities in the Assessment of Lateral Epicondylosis. J Ultrasound Med. 2018 Mar;37(3):585-593. doi: 10.1002/jum.14369. Epub 2017 Aug 29.
PubMed 28850740
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Clinical Correlation of Tendons With Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients With Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07127302
- Acronym / sponsor ID
- 19-2025/10
- Keywords
- Lateral epicondylitis, Ultrasonographic diagnosis, Doppler Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahmet YesildagUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 17 Aug 2025 (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.
Evaluation and Clinical Correlation of Tendons Using Power Doppler, SWE, Microvascular Flow (MV-Flow) Imaging and B-Mode Ultrasonography in Patients with Lateral Epicondylitis.
Detailed description
The aim of the study was to perform tendon evaluation using different ultrasonography methods in patients with a diagnosis or prediagnosis of lateral epicondylitis and to determine the correlation between clinical findings and ultrasonographic findings. Hemodynamic and elastic properties of pathologic tendons will be examined using Power Doppler, Shear Wave Elastography (SWE), Microvascular Flow (MV-Flow) and B-Mode Ultrasonography methods.
In addition, clinical scoring of the cases will be compared with positive wrist extension tests agonist resistance (Cozen test) duration of pain in the lateral epicondyle region (weeks), VAS pain score at rest, VAS pain score during activity, VAS pain score during maximal grip, VAS pain score during maximal grip, and US findings to determine the ultrasonography technique with the highest clinical correlation.
In addition, the differences between pathologic tendons and normal tendons will be evaluated to determine the Doppler US findings with the highest diagnostic performance.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lateral epicondylitis or suspected lateral epicondylitis
Key inclusion criteria (1 listed)
- Lateral epicondylitis
Key exclusion criteria (1 listed)
- -
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
The relationship between clinical scores and ultrasound findings in patients with lateral epicondylitis.
Time frame: 3-5 months
Correlation or logistic statistical analyses will be applied to reveal the relationship between ultrasound methods and clinical scores.
1 secondary outcome
Comparison of ultrasound findings in pathological tendons and normal tendons and demonstration of the diagnostic performance of ultrasound methods
Time frame: 3-5 Month
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 3 Mar 2026.
- Background: PubMed 18036844Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26.
- Background: PubMed 32775379Zhou J, Yang DB, Wang J, Li HZ, Wang YC. Role of shear wave elastography in the evaluation of the treatment and prognosis of supraspinatus tendinitis. World J Clin Cases. 2020 Jul 26;8(14):2977-2987. doi: 10.12998/wjcc.v8.i14.2977.
- Background: PubMed 32851377Unal OF, BayramoGlu Z, AdaletlI I. Evaluation of Periarticular Soft Tissues in Patients With Juvenile Idiopathic Arthritis by Superb Microvascular Imaging and Shear Wave Elastography. Arch Rheumatol. 2020 Feb 7;35(2):264-273. doi: 10.46497/ArchRheumatol.2020.7640. eCollection 2020 Jun.
- Background: PubMed 32020529Gitto S, Messina C, Chianca V, Tuscano B, Lazzara A, Corazza A, Pedone L, Albano D, Sconfienza LM. Superb microvascular imaging (SMI) in the evaluation of musculoskeletal disorders: a systematic review. Radiol Med. 2020 May;125(5):481-490. doi: 10.1007/s11547-020-01141-x. Epub 2020 Feb 4.
- Background: PubMed 29789266Praet SFE, Ong JH, Purdam C, Welvaert M, Lovell G, Dixon L, Gaida JE, Anglim J, Manzanero S, Vlahovich N, Hughes D, Waddington G. Microvascular volume in symptomatic Achilles tendons is associated with VISA-A score. J Sci Med Sport. 2018 Dec;21(12):1185-1191. doi: 10.1016/j.jsams.2018.05.013. Epub 2018 May 15.
- Background: PubMed 28850740Arslan S, Karahan AY, Oncu F, Bakdik S, Durmaz MS, Tolu I. Diagnostic Performance of Superb Microvascular Imaging and Other Sonographic Modalities in the Assessment of Lateral Epicondylosis. J Ultrasound Med. 2018 Mar;37(3):585-593. doi: 10.1002/jum.14369. Epub 2017 Aug 29.
- Individual participant dataSharing planned: Undecided
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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.
Ahmet Yeşildağ, Prof.Dr. study director
Karamanoğlu Mehmetbey Universty
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 Elastography, run by Ahmet Yesildag 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 3 Mar 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?
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?
The relationship between clinical scores and ultrasound findings in patients with lateral epicondylitis. (time frame: 3-5 months). 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 NCT07127302, which also lists 6 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 3 Mar 2026.