Reliability and Accuracy of a New Clinical Test for Biceps Lesions

NCT07531225 | Not Yet Recruiting

• 1 other identifier: Biceps Lesion Test Accuracy
• Study Type: observational
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lesion of Long Head of Biceps; SLAP Lesion; Biceps Tendinopathy; Rotator Cuff Tear; Shoulder Injuries; Biceps Instability

Keywords

Said's Test; Speed's Test; O'Brien Test; Long Head of the Biceps; Bicipital Groove; Diagnostic Accuracy; Sensitivity and Specificity; Inter-observer Reliability

Outcome Measures

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).

  Up to 1 month (From the time of the initial clinical examination to the confirmatory imaging or surgical assessment)

Study Arms (3)

Group A: Isolated SLAP Lesion

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).

Group B: Complex Biceps and Rotator Cuff Lesions

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).

Group C: Control Group

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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).

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Injuries; Hypersensitivity

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Orthopaedic and Trauma Department, Assiut University

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04