Reliability and Accuracy of a New Clinical Test for Biceps Lesions

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

144 Participants
are grouped into 3 trial groups
Group A: Group A: Isolated SLAP Lesion
Group B: Group B: Complex Biceps and Rotator Cuff Lesions
Group C: Group C: Control Group

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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