NCT04954170

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2013

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

July 5, 2021

Last Update Submit

July 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • patient-reported pain

    patients feeling severe pain when accomplishing the test

    immediately after the test

Study Arms (1)

RCT patients

Patients suffering from rotator cuff injury

Diagnostic Test: IRRTMDiagnostic Test: the lift-off testDiagnostic Test: the belly-press testDiagnostic Test: the IRLS testDiagnostic Test: the bear-hug testDiagnostic Test: IRRT 0°Diagnostic Test: Diagnostic arthroscopy

Interventions

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.

RCT patients
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.

RCT patients
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.

RCT patients
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.

RCT patients
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.

RCT patients
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.

RCT patients
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.

RCT patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • patients suffering from rotator cuff injury

You may not qualify if:

  • patients with shoulder stiffness, instability, calcifying tendinitis, previous surgery and on the contralateral shoulder with diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PekingUTH

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Guoqing Cui

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 8, 2021

Study Start

February 1, 2012

Primary Completion

May 31, 2013

Study Completion

May 31, 2013

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations