Lesion of Long Head of BicepsNCT07531225
Reliability and Accuracy of a New Clinical Test for Biceps Lesions
An observational study of Lesion of Long Head of Biceps and SLAP Lesion, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lesion of Long Head of Biceps, SLAP Lesion, Biceps Tendinopathy
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
About this study
Official title: Sensitivity and Specificity and Inter-Observer Reliability of a New Test for Lesion of the Long Head of the Biceps
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.
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Injuries, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 1 month (From the time of the initial clinical examination to the confirmatory imaging or surgical assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lesion of Long Head of BicepsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelraof Khalaf Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531225
- Sponsor's protocol ID
- Biceps Lesion Test Accuracy
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity and Inter-Observer Reliability of a New Test for Lesion of the Long Head of the Biceps
- ClinicalTrials.gov ID
- NCT07531225
- Acronym / sponsor ID
- Biceps Lesion Test Accuracy
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
Related trials for Lesion of Long Head of Biceps
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Recruiting
Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears
Rotator Cuff Tears, Rotator Cuff Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lesion of Long Head of Biceps and SLAP Lesion, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.