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NCT07531225

Reliability and Accuracy of a New Clinical Test for Biceps Lesions

Sponsor: Assiut University

View on ClinicalTrials.gov

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.

Official title: Sensitivity and Specificity and Inter-Observer Reliability of a New Test for Lesion of the Long Head of the Biceps

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

144

Start Date

2026-05

Completion Date

2027-06

Last Updated

2026-04-15

Healthy Volunteers

Not specified