Diagnostic Accuracy of the Clinical Tests and the Ultrasonography in Lateral Elbow Tendinopathy

January 11, 2026 updated by: İlker Yağcı, Marmara University

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkey (Türkiye), 34844
        • Recruiting
        • Marmara University
        • Principal Investigator:
          • İlker Yağcı, Prof. M.D.
        • Sub-Investigator:
          • Naime Evrim Karadağ Saygı, Prof. M.D.
        • Contact:
        • Sub-Investigator:
          • Arda Can Kasap, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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:

  • 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.

Exclusion Criteria:

  • History of rheumatologic diseases
  • History of e corticosteroid injections on lateral epicondyle
  • History of elbow surgery or infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Healthy volunteers with similar demographic characteristics will be enrolled to this group.
Lateral elbow tendinopathy
Patients with lateral epicondylitis will be included in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Musculoskeletal ultrasound
Time Frame: At enrollment
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.
At enrollment
Cozen's test
Time Frame: At enrollment
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.
At enrollment
Maudsley's Test
Time Frame: At enrollment
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.
At enrollment
Mill's test
Time Frame: At enrollment
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.
At enrollment
Hand Grip Strength
Time Frame: At enrollment
Both painless and maximum grip strength will be examined using Jamar's hand dynamometer.
At enrollment
Algometer
Time Frame: At enrollment
Force will be applied to lateral epicondyle using an algometer.
At enrollment
Patient Rated Tennis Elbow Evaluation
Time Frame: At enrollment
Patient Rated Tennis Elbow Evaluation will be used to assess pain and functional status in patients diagnosed with LET.
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: İlker Yağcı, Prof. M.D., Acıbadem Ataşehir Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

March 26, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2025.25-0880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to legal restrictions, all data will be anonymized. Individual participant data won't be shared to third parties.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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