Reliability and Accuracy of a New Clinical Test for Biceps Lesions

Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

• Sensitivity of the New Clinical Test (Said's Test) [Time frame: Up to 1 month (From the time of the initial clinical examination to the confirmatory imaging or surgical assessment)]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07531225 · Biceps Lesion Test Accuracy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗