Reliability and Accuracy of a New Clinical Test for Biceps Lesions
Starting soon
Conditions studied: Lesion of Long Head of Biceps, SLAP Lesion, Biceps Tendinopathy, Rotator Cuff Tear, Shoulder Injuries, Biceps Instability
In brief
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.
Key facts
- Study ID
- NCT07531225
- Run by
- Assiut University
- People needed
- 144
- Starts
- 2026-05-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients aged 18-70 years presenting with shoulder pain suggestive of biceps pathology.
- Healthy individuals matched to age, sex, and level of activities to serve as a control group (or the normal contralateral shoulder of the same patient).
You may not qualify if…
- Patients who prefer conservative treatment.
- Patients who have biceps belly (biceps fibers) tears.
- Patients with an unstable shoulder because of the risk of dislocation during performing the new test.
- Patients with a history of shoulder surgery within the past 6 months.
- Patients with systemic inflammatory conditions affecting the joints (e.g., rheumatoid arthritis).
- Patients unable to cooperate with physical examination.
- Patients with contraindications to the gold standard diagnostic method (e.g., MRI contraindications).
Full record on ClinicalTrials.gov
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