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NCT Number: NCT07347873

Diagnostic Accuracy of the Clinical Tests and the 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, Maltepe, 34844, Turkey (Türkiye)

Location status: Recruiting

Location contact

Arda Can Kasap, M.D.

CONTACT

[email protected]

902166254545

Arda Can Kasap, M.D.

SUB_INVESTIGATOR

Naime Evrim Karadağ Saygı, Prof. M.D.

SUB_INVESTIGATOR

İlker Yağcı, Prof. M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Hand Grip Strength

    Time frame: At enrollment

    Both painless and maximum grip strength will be examined using Jamar's hand dynamometer.

  6. Algometer

    Time frame: At enrollment

    Force will be applied to lateral epicondyle using an algometer.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arda Can Kasap, M.D.

CONTACT

[email protected]

+902166254545

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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