Diagnostic Accuracy of the Clinical Tests and the Ultrasonography in Lateral Elbow Tendinopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
History of rheumatologic diseases
History of e corticosteroid injections on lateral epicondyle
History of elbow surgery or infection
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Lateral elbow tendinopathy
Group B: Control
Trial outcomes
Primary outcomes
1
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.
Time frame
At enrollmentSecondary outcomes
1
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.
Time frame
At enrollment2
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.
Time frame
At enrollment3
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.
Time frame
At enrollment4
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.
Time frame
At enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov