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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07347873
Enrollment
100
Registered
2026-01-16
Start date
2025-10-17
Completion date
2026-03-26
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Elbow Tendinopathy (Tennis Elbow)

Keywords

Elbow pain, Lateral epicondylitis, Cozen, Elastography

Brief 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. Purpose of this study is to determine the sensitivity and specificity of clinical tests and ultrasonography in diagnosis of LET.

Interventions

None listed

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ElastographyAt enrollmentBoth 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

MeasureTime frameDescription
Hand Grip StrengthAt enrollmentBoth painless and maximum grip strength will be examined using Jamar's hand dynamometer.
AlgometerAt enrollmentForce will be applied to lateral epicondyle using an algometer.
Musculoskeletal ultrasoundAt enrollmentSonographic 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.
Patient Rated Tennis Elbow EvaluationAt enrollmentPatient Rated Tennis Elbow Evaluation will be used to assess pain and functional status in patients diagnosed with LET.
Maudsley's TestAt enrollmentResisted 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.
Mill's testAt enrollmentMaximal 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.
Cozen's testAt enrollmentResisted 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactArda Can Kasap, M.D.
drardakasap@gmail.com+902166254545

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026