Rotator Cuff TearsNCT04954170
Internal Rotation Resistance Test at Abduction and External Rotation
An observational study of Rotator Cuff Tears, run by Peking University Third Hospital at 1 site in China.
Trial summary
A new clinical test for evaluating subscapularis (SSC) integrity was described, and its diagnostic value was compared with the present SSC tests (the lift-off, bellypress, IRLS and bear-hug tests). The new test is called internal rotation resistance test at abduction and external rotation (IRRT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- IRRTM, the lift-off test and the belly-press test
- How many people
- 235 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2012to 31 May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two hundred and thirty-five consecutive patients including 107 men and 128 women with the mean age 51 ± 18.3 years (range from 26 to 76 years) were evaluated. There were 173 right and 62 left shoulders.
Who may be able to join
- patients suffering from rotator cuff injury
Who cannot join
- patients with shoulder stiffness, instability, calcifying tendinitis, previous surgery and on the contralateral shoulder with diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Rotation Resistance Test at Abduction and External Rotation: a New Clinical Test for Diagnosing Subscapularis Lesions
A new clinical test for evaluating subscapularis (SSC) integrity was described, and its diagnostic value was compared with the present SSC tests (the lift-off, bellypress, IRLS and bear-hug tests). The new test is called internal rotation resistance test at abduction and external rotation (IRRT). The test is performed at maximal 90° of abduction and maximal external rotation. Two hundred and thirty-five consecutive patients suffering from rotator cuff injury were evaluated preoperatively. Six tests were performed to assess the function of the SSC: the lift-off, belly-press, IRLS, the bear-hug, IRRT at 0° abduction and 0° external rotation (IRRT0°) and IRRT at maximal 90° abduction and maximal external rotation (IRRTM). Arthroscopic findings were the reference for diagnosing of SSC lesions.
Read the detailed description
The subscapularis (SSC) provides 50 % of total rotator cuff strength and constitutes the anterior part of force couples of the glenohumeral joint. The advances in shoulder arthroscopy have resulted in improved detection and treatment of subscapularis tendon pathology. The prevalence is between 27 and 30 % in all shoulder arthroscopies and between 49 and 59 % in arthroscopic rotator cuff surgery .
It would be advantageous for the surgeon to be able to diagnose a SSC tear clinically before surgery is performed for rotator cuff tear. Magnetic resonance imaging (MRI) scans of the shoulder have been widely used as a diagnostic tool for predicting the rotator cuff injuries. But preoperative MRI scans do not reliably predict SSC tears, whether conventional MRI or MR arthrography is used. Many clinical tests have been published to evaluate the integrity of SSC. The first of these was the lift-off test by Gerber that was reported to be very reliable in patients with complete SSC tears. The internal rotation lag sign (IRLS) published by Hertel et al. was specific but more sensitive than the lift-off test for assessing the SSC. The belly-press test described by Gerber et al. was modified by other authors who called it the Napoleon sign or the modified belly-press test. Positive belly-press tests were found with upper-third SSC tears. More recently, the bear-hug test was published by Barth et al. and represented the most sensitive test compared with lift-off, belly-press and Napoleon tests. However, Yoon et al. found belly-press test was more sensitive compared with bear-hug test in the most recent study. In our institute, we also performed internal rotation resistance test (IRRT) at 0° abduction and 0° external rotation (IRRT0°, Fig. 1) and IRRT at maximal 90° abduction and maximal external rotation (IRRTM) to investigate the function of SSC. These tests use resisted internal rotation as the shoulder is at different abduction and external rotation degrees.
Although many of these tests are performed, SSC lesions are still underdiagnosed before operation. Because these 6 tests mentioned above have a distinct position and manner, the individual test might imply different severity of SSC lesions. The SSC is stretched out and more extension in the abduction and external rotation position compared with internal rotation position. The purpose of this study is to describe the new clinical test (IRRTM) for evaluating SSC integrity and to compare its diagnostic value with the present SSC tests (the lift-off, belly-press, IRLS and bear-hug tests). The hypothesis was that the IRRTM would be the most sensitive test for detecting tears of the SSC.
- Conditions
- Rotator Cuff Tears
- Being tested
- IRRTM, the lift-off test, the belly-press test, the IRLS test, the bear-hug test
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRRTMDiagnostic test
IRRT at maximal 90° abduction and maximal external rotation is performed with the shoulder at maximal 90° rotation and the elbow flexed to 90° (Fig. 2). The patient is then asked to resist the external rotation force applied perpendicular to the forearm by the investigator. The test is considered positive if the patient could not hold the position or if he or she showed weakness of resisted internal rotation compared with the other side. It should be noted the maximal 90° abduction and maximal external rotation is active range of motion. Passive motion may affect the result of the test because of severe pain.
the lift-off testDiagnostic test
The lift-off test is performed by placing the hand of the affected arm on the back (at the position of the midlumbar spine) and asking the patient to internally rotate the arm to lift the hand off the back [9]. The test is considered positive if the patient is unable to lift the arm posteriorly off the back or if he or she performs the lifting manoeuvre by extending the elbow or the shoulder. Weakness is also as a positive result.
the belly-press testDiagnostic test
The belly-press test is performed with the arm at the side and the elbow flexed to 90°, by having the patient press the palm into his or her abdomen by internally rotating the shoulder [3, 5]. The test is considered positive (1) if the patient shows a weakness in comparison with the opposite shoulder or (2) the patient pushes the hand against the belly by wrist flexion, despite instruction to the contrary.
the IRLS testDiagnostic test
IRLS test is evaluated with the affected arm of the patient was held by the examiner at maximum internal rotation [10]. The back of the hand is then passively lifted away from the body until almost full internal rotation is reached. Then, the patient is asked to actively maintain this position. The test is considered positive when the patient fails to maintain the position and the hand lagged.
the bear-hug testDiagnostic test
The bear-hug test is performed with the palm of one side placed on the opposite shoulder and fingers extended and the elbow positioned anterior to the body [3]. The patient is then asked to hold that position when the examiner tried to pull the patient's hand from the shoulder with an external rotation force applied perpendicular to the forearm. The test is considered positive if the patient could not hold the hand against the shoulder or if he or she showed weakness compared with the other side.
IRRT 0°Diagnostic test
IRRT at 0° abduction and 0° external rotation is performed with the arm at the side and the elbow flexed to 90° (Fig. 1). The patient is then asked to resist the external rotation force applied by the investigator. The test is considered positive if the patient could not hold the position at the side or if he or she showed weakness of resisted internal rotation compared with the other side. The test is negative if patients only complain of pain.
Diagnostic arthroscopyDiagnostic test
At the time of surgery, general anaesthesia was administered and the patient was placed in beach-chair position. A complete arthroscopic exploration of the glenohumeral joint and the subacromial space was performed through a standard posterior portal. The senior author performed a complete arthroscopic exploration. Arthroscopic evaluation of the rotator cuff was considered the gold standard for making the definitive diagnosis. Evaluation of the SSC was carried out with both a 30° arthroscope and a 70° arthroscope.
| Study group | Role | What they receive |
|---|---|---|
| RCT patients | Patients suffering from rotator cuff injury Receives: Diagnostic Test: IRRTM; Diagnostic Test: the lift-off test; Diagnostic Test: the belly-press test; Diagnostic Test: the IRLS test; Diagnostic Test: the bear-hug test; Diagnostic Test: IRRT 0°; Diagnostic Test: Diagnostic arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported pain
patients feeling severe pain when accomplishing the test
Measured: immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Feb 2012
- Primary completion31 May 2013
- Study completion31 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954170
- Sponsor's protocol ID
- 2013125
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Rotation Resistance Test at Abduction and External Rotation: a New Clinical Test for Diagnosing Subscapularis Lesions
- ClinicalTrials.gov ID
- NCT04954170
- Acronym / sponsor ID
- 2013125
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 8 Jul 2021 (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.
A new clinical test for evaluating subscapularis (SSC) integrity was described, and its diagnostic value was compared with the present SSC tests (the lift-off, bellypress, IRLS and bear-hug tests). The new test is called internal rotation resistance test at abduction and external rotation (IRRT). The test is performed at maximal 90° of abduction and maximal external rotation. Two hundred and thirty-five consecutive patients suffering from rotator cuff injury were evaluated preoperatively. Six tests were performed to assess the function of the SSC: the lift-off, belly-press, IRLS, the bear-hug, IRRT at 0° abduction and 0° external rotation (IRRT0°) and IRRT at maximal 90° abduction and maximal external rotation (IRRTM). Arthroscopic findings were the reference for diagnosing of SSC lesions.
Detailed description
The subscapularis (SSC) provides 50 % of total rotator cuff strength and constitutes the anterior part of force couples of the glenohumeral joint. The advances in shoulder arthroscopy have resulted in improved detection and treatment of subscapularis tendon pathology. The prevalence is between 27 and 30 % in all shoulder arthroscopies and between 49 and 59 % in arthroscopic rotator cuff surgery .
It would be advantageous for the surgeon to be able to diagnose a SSC tear clinically before surgery is performed for rotator cuff tear. Magnetic resonance imaging (MRI) scans of the shoulder have been widely used as a diagnostic tool for predicting the rotator cuff injuries. But preoperative MRI scans do not reliably predict SSC tears, whether conventional MRI or MR arthrography is used. Many clinical tests have been published to evaluate the integrity of SSC. The first of these was the lift-off test by Gerber that was reported to be very reliable in patients with complete SSC tears. The internal rotation lag sign (IRLS) published by Hertel et al. was specific but more sensitive than the lift-off test for assessing the SSC. The belly-press test described by Gerber et al. was modified by other authors who called it the Napoleon sign or the modified belly-press test. Positive belly-press tests were found with upper-third SSC tears. More recently, the bear-hug test was published by Barth et al. and represented the most sensitive test compared with lift-off, belly-press and Napoleon tests. However, Yoon et al. found belly-press test was more sensitive compared with bear-hug test in the most recent study. In our institute, we also performed internal rotation resistance test (IRRT) at 0° abduction and 0° external rotation (IRRT0°, Fig. 1) and IRRT at maximal 90° abduction and maximal external rotation (IRRTM) to investigate the function of SSC. These tests use resisted internal rotation as the shoulder is at different abduction and external rotation degrees.
Although many of these tests are performed, SSC lesions are still underdiagnosed before operation. Because these 6 tests mentioned above have a distinct position and manner, the individual test might imply different severity of SSC lesions. The SSC is stretched out and more extension in the abduction and external rotation position compared with internal rotation position. The purpose of this study is to describe the new clinical test (IRRTM) for evaluating SSC integrity and to compare its diagnostic value with the present SSC tests (the lift-off, belly-press, IRLS and bear-hug tests). The hypothesis was that the IRRTM would be the most sensitive test for detecting tears of the SSC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RCT patients | – | Diagnostic Test: IRRTM, Diagnostic Test: the lift-off test, Diagnostic Test: the belly-press test, Diagnostic Test: the IRLS test, Diagnostic Test: the bear-hug test, Diagnostic Test: IRRT 0°, Diagnostic Test: Diagnostic arthroscopyPatients suffering from rotator cuff injury |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two hundred and thirty-five consecutive patients including 107 men and 128 women with the mean age 51 ± 18.3 years (range from 26 to 76 years) were evaluated. There were 173 right and 62 left shoulders.
Key inclusion criteria (1 listed)
- patients suffering from rotator cuff injury
Key exclusion criteria (1 listed)
- patients with shoulder stiffness, instability, calcifying tendinitis, previous surgery and on the contralateral shoulder with diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRRTMIRRT at maximal 90° abduction and maximal external rotation is performed with the shoulder at maximal 90° rotation and the elbow flexed to 90° (Fig. 2). The patient is then asked to resist the external rotation force applied perpendicular to the forearm by the investigator. The test is considered positive if the patient could not hold the position or if he or she showed weakness of resisted internal rotation compared with the other side. It should be noted the maximal 90° abduction and maximal external rotation is active range of motion. Passive motion may affect the result of the test because of severe pain. | Diagnostic test | RCT patients |
| the lift-off testThe lift-off test is performed by placing the hand of the affected arm on the back (at the position of the midlumbar spine) and asking the patient to internally rotate the arm to lift the hand off the back [9]. The test is considered positive if the patient is unable to lift the arm posteriorly off the back or if he or she performs the lifting manoeuvre by extending the elbow or the shoulder. Weakness is also as a positive result. | Diagnostic test | RCT patients |
| the belly-press testThe belly-press test is performed with the arm at the side and the elbow flexed to 90°, by having the patient press the palm into his or her abdomen by internally rotating the shoulder [3, 5]. The test is considered positive (1) if the patient shows a weakness in comparison with the opposite shoulder or (2) the patient pushes the hand against the belly by wrist flexion, despite instruction to the contrary. | Diagnostic test | RCT patients |
| the IRLS testIRLS test is evaluated with the affected arm of the patient was held by the examiner at maximum internal rotation [10]. The back of the hand is then passively lifted away from the body until almost full internal rotation is reached. Then, the patient is asked to actively maintain this position. The test is considered positive when the patient fails to maintain the position and the hand lagged. | Diagnostic test | RCT patients |
| the bear-hug testThe bear-hug test is performed with the palm of one side placed on the opposite shoulder and fingers extended and the elbow positioned anterior to the body [3]. The patient is then asked to hold that position when the examiner tried to pull the patient's hand from the shoulder with an external rotation force applied perpendicular to the forearm. The test is considered positive if the patient could not hold the hand against the shoulder or if he or she showed weakness compared with the other side. | Diagnostic test | RCT patients |
| IRRT 0°IRRT at 0° abduction and 0° external rotation is performed with the arm at the side and the elbow flexed to 90° (Fig. 1). The patient is then asked to resist the external rotation force applied by the investigator. The test is considered positive if the patient could not hold the position at the side or if he or she showed weakness of resisted internal rotation compared with the other side. The test is negative if patients only complain of pain. | Diagnostic test | RCT patients |
| Diagnostic arthroscopyAt the time of surgery, general anaesthesia was administered and the patient was placed in beach-chair position. A complete arthroscopic exploration of the glenohumeral joint and the subacromial space was performed through a standard posterior portal. The senior author performed a complete arthroscopic exploration. Arthroscopic evaluation of the rotator cuff was considered the gold standard for making the definitive diagnosis. Evaluation of the SSC was carried out with both a 30° arthroscope and a 70° arthroscope. | Diagnostic test | RCT patients |
Primary outcome
patient-reported pain
Time frame: immediately after the test
patients feeling severe pain when accomplishing the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Guoqing Cui study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patient-reported pain (time frame: immediately after the test). 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 8 Jul 2021.