An observational study in Lesion of Long Head of Biceps, SLAP Lesion and Biceps Tendinopathy, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Assiut University · Observational
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.
Pathologies of the long head of the biceps, including tendinopathy, partial or complete tears, tendon instability, and SLAP lesions, are a common cause of shoulder pain and disability. These lesions frequently arise from overhead activities, degenerative changes, or acute traumatic events, and they can coexist with other shoulder conditions like rotator cuff tears, which often complicates diagnosis and management. While several clinical tests currently exist for diagnosing biceps and SLAP lesions (such as O'Brien's test, the Crank test, and Speed's test), they vary considerably in their sensitivity and specificity.
This prospective case-control study aims to evaluate the diagnostic accuracy and inter-observer reliability of a novel physical examination maneuver, referred to as "Said's test," designed specifically to detect lesions of the long head of the biceps.
To ensure rigorous methodology and accurate assessment of inter-observer reliability, each enrolled participant will be evaluated by two independent examiners in an outpatient clinic setting. These examiners will be strictly blinded to each other's clinical findings, as well as to any prior radiological results. Prior to the study's commencement, all examiners will undergo standardized training, utilizing a detailed manual, photographs, and video demonstrations, to ensure the proper execution and consistent interpretation of the new clinical test.
During the clinical assessment, each examiner will perform the new Said's test alongside classic physical tests (Speed's and O'Brien test) for direct comparison. The new Said's test is performed with the patient lying down, the examiner brings the patient's arm into 120 degrees of abduction with full external rotation, then moves the elbow toward the patient's abdomen while maintaining that position. The test is considered positive if the patient experiences deep pain in the shoulder. Test results will be recorded as either positive or negative.
Following the physical examinations, clinical findings will be validated against gold-standard diagnostic methods. Patients in the symptomatic groups will undergo a native MRI of the shoulder. If a SLAP lesion is highly suggested by the clinical examination but is not clearly visible on the native MRI, a Magnetic Resonance Angiography (MRA) will be ordered, or the patient will undergo diagnostic arthroscopy to confirm the presence or absence of the lesion. Participants in the asymptomatic control group will not routinely undergo MRI or arthroscopy, though these may be suggested if their clinical tests return unexpectedly positive results. All gold-standard imaging and surgical assessments will be interpreted by experienced radiologists or surgeons who are blinded to the results of the novel clinical test.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 144 is above the median of 70 across 145 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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The study population consists of patients aged 18 to 70 years presenting to the outpatient clinic at Assiut University Trauma Hospital with shoulder pain suggestive of a biceps pathology. The population also includes a control group of healthy individuals matched for age, sex, and activity level, or the asymptomatic contralateral shoulder of the enrolled patients.
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Exclusion Criteria:
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Patients aged 18-70 years presenting with shoulder pain who are subsequently diagnosed with an isolated SLAP lesion. All participants in this group will undergo physical examination using the new Said's test, as well as the classical Speed's and O'Brien tests. The diagnosis will be confirmed via the gold standard (MRI, MRA, or arthroscopy).
Patients aged 18-70 years presenting with shoulder pain who are diagnosed with a SLAP lesion associated with a rotator cuff tear, an isolated rotator cuff tear, or other biceps lesions. All participants in this group will undergo physical examination using the new Said's test, as well as the classical Speed's and O'Brien tests. The diagnosis will be confirmed via the gold standard (MRI, MRA, or arthroscopy).
A control group consisting of healthy individuals matched for age, sex, and activity level, or the asymptomatic, normal contralateral shoulder of patients in the other groups. Subjects in this group will undergo the physical examinations (Said's, Speed's, and O'Brien tests). In this group, MRI or arthroscopy will not be routinely performed unless suggested by positive clinical test results.
Sensitivity of the New Clinical Test (Said's Test)
The sensitivity of Said's test for diagnosing lesions of the long head of the biceps will be evaluated. It will be calculated as the proportion of positive clinical test results among participants who have a confirmed biceps pathology. The clinical findings will be validated against the gold standard definitive diagnosis (MRI, MRA, or intraoperative arthroscopic findings).
Time frame: Up to 1 month (From the time of the initial clinical examination to the confirmatory imaging or surgical assessment)
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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