NCT04954508

Brief Summary

We developed a new test, the "hug-up test," wherein elevation is resisted as the palm is held on the opposite shoulder with the elbow held in maximal anterior translation. The purpose of this study was to describe the hug-up test and compare it with other conventional tests used for diagnosing supraspinatus tears.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

December 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2014

Completed
7.4 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

1.2 years

First QC Date

July 5, 2021

Last Update Submit

July 5, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • patients' self-reported pain

    Pain experienced during the Neer impingement and Hawkins-Kennedy impingement tests and weakness during the EC test and the FC test were considered positive results.

    immediately after the test

  • diagnostic arthroscopy

    The arthroscopic operation involved complete inspection of the supraspinatus. Supraspinatus tears were categorized as fullthickness tears (FTTs), which were classified as small (≤1 cm), moderate (≤3 cm), large (≤5 cm), and massive (\>5 cm), on the basis of the largest dimension, and partial-thickness tears (PTTs), which were classified as bursal-sided, articular-sided,and intra-tendinous. Other combined diseases including acromioclavicular joint derangement, infraspinatus lesions, subscapularis lesions, superior labrum anterior and posterior (SLAP) lesions, biceps disorders, and Bankart lesions were recorded as well to assess the specificity of the tests.the supraspinatus. Supraspinatus tears were categorized as fullthickness tears (FTTs), which were classified as small (≤1 cm), moderate (≤3 cm), large (≤5 cm), and massive (\>5 cm), on the basis of the largest dimension, and partial-thickness tears (PTTs), which were classified as bursal-sided, articular-sided,

    during the arthrosocpic procedure

Study Arms (1)

P

patients suffering form shoulder pain and/or weakness or dislication

Diagnostic Test: The hug-up testDiagnostic Test: EC testDiagnostic Test: FC testDiagnostic Test: Neer impingement signDiagnostic Test: Hawkins-Kennedy impingement signDiagnostic Test: diagnostic arthroscopy

Interventions

The hug-up testDIAGNOSTIC_TEST

It is a new physical test used to detect supraspinatus tear

P
EC testDIAGNOSTIC_TEST

It is a traditional physical test used to detect supraspinatus tear

P
FC testDIAGNOSTIC_TEST

It is a traditional physical test used to detect supraspinatus tear

P
Neer impingement signDIAGNOSTIC_TEST

It is a traditional physical test used to detect supraspinatus tear

P

It is a traditional physical test used to detect supraspinatus tear

P
diagnostic arthroscopyDIAGNOSTIC_TEST

The arthroscopic operation involved complete inspection of the supraspinatus. Supraspinatus tears were categorized as fullthickness tears (FTTs), which were classified as small (≤1 cm), moderate (≤3 cm), large (≤5 cm), and massive (\>5 cm), on the basis of the largest dimension, and partial-thickness tears (PTTs), which were classified as bursal-sided, articular-sided,and intra-tendinous. Other combined diseases including acromioclavicular joint derangement, infraspinatus lesions, subscapularis lesions, superior labrum anterior and posterior (SLAP) lesions, biceps disorders, and Bankart lesions were recorded as well to assess the specificity of the tests.

P

Eligibility Criteria

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

200 consecutive patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors.

You may qualify if:

  • patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors from November 2012 to January 2014

You may not qualify if:

  • Patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Yulei Liu

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 8, 2021

Study Start

December 1, 2012

Primary Completion

January 31, 2014

Study Completion

January 31, 2014

Last Updated

July 8, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations