Clinical Trial

Reliability and Accuracy of a New Clinical Test for Biceps Lesions

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Summary
The purpose of this study is to evaluate the accuracy and reliability of a new physical examination test (referred to as Said's test) for diagnosing injuries to the biceps tendon in the shoulder, specifically lesions of the long head of the biceps and SLAP tears. Diagnosing biceps injuries during a physical exam can be challenging, and existing standard tests can vary in their accuracy. This study aims to determine if this newly developed physical test is a more sensitive, specific, and reliable tool for doctors to use in a clinical setting. The study will enroll 144 adult participants (ages 18 to 70). These participants will be categorized into three groups: patients with isolated SLAP lesions, patients with complex shoulder injuries (such as a rotator cuff tear combined with a biceps lesion), and a control group of healthy individuals or asymptomatic shoulders. During the study, each participant will be examined by two independent doctors who are blinded to the patient's actual diagnosis. The doctors will perform the new physical test alongside traditional shoulder tests (the Speed's and O'Brien tests). To determine the true accuracy of these physical exams, the doctors' findings will be compared against definitive diagnostic methods, which will include an MRI, an MRA, or direct visualization during shoulder arthroscopy. By comparing the physical exam results to the gold standard imaging or surgical findings, researchers will calculate the new test's sensitivity, specificity, and inter-observer reliability.
Trial Details
NCT Number NCT07531225
Lead Sponsor Assiut University
Conditions Lesion of Long Head of Biceps, SLAP Lesion, Biceps Tendinopathy, Rotator Cuff Tear, Shoulder Injuries, Biceps Instability
Enrollment 144 participants
Start Date 2026-05
Primary Completion 2027-05 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-15