Rotator Cuff TearsNCT04954508
The Hug-up Test: A New, Sensitive Diagnostic Test for Supraspinatus Tears
An observational study of Rotator Cuff Tears, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- The hug-up test, EC test and FC test
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2012to 31 Jan 2014
- How long will I take part?
- 1 Month
- 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: 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.
Who may be able to join
- 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
Who cannot join
- Patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the detailed description
The supraspinatus tendon is the most commonly affected tendon in rotator cuff tears. Early detection of a supraspinatus tear using an accurate physical examination is, therefore, important. However, the currently used physical tests for detecting supraspinatus tears are poor diagnostic indicators and involve a wide range of sensitivity and specificity values. Therefore, the aim of this study was to establish a new physical test for the diagnosis of supraspinatus tears and evaluate its accuracy in comparison with conventional tests.
Between November 2012 and January 2014, 200 consecutive patients undergoing shoulder arthroscopy were prospectively evaluated preoperatively. The hug-up test, empty can (EC) test, full can (FC) test, Neer impingement sign, and Hawkins-Kennedy impingement sign were used and compared statistically for their accuracy in terms of supraspinatus tears, with arthroscopic findings as the gold standard. Muscle strength was precisely quantified using an electronic digital tensiometer.
- Conditions
- Rotator Cuff Tears
- Being tested
- The hug-up test, EC test, FC test, Neer impingement sign, Hawkins-Kennedy impingement sign
- 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.
The hug-up testDiagnostic test
It is a new physical test used to detect supraspinatus tear
EC testDiagnostic test
It is a traditional physical test used to detect supraspinatus tear
FC testDiagnostic test
It is a traditional physical test used to detect supraspinatus tear
Neer impingement signDiagnostic test
It is a traditional physical test used to detect supraspinatus tear
Hawkins-Kennedy impingement signDiagnostic test
It is a traditional physical test used to detect supraspinatus tear
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.
| Study group | Role | What they receive |
|---|---|---|
| P | patients suffering form shoulder pain and/or weakness or dislication Receives: Diagnostic Test: The hug-up test; Diagnostic Test: EC test; Diagnostic Test: FC test; Diagnostic Test: Neer impingement sign; Diagnostic Test: Hawkins-Kennedy impingement sign; Diagnostic Test: diagnostic arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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,
Measured: during the arthrosocpic procedure
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 Dec 2012
- Primary completion31 Jan 2014
- Study completion31 Jan 2014
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yulei Liu, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954508
- Sponsor's protocol ID
- 2014156
- 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
- The Hug-up Test: A New, Sensitive Diagnostic Test for Supraspinatus Tears
- ClinicalTrials.gov ID
- NCT04954508
- Acronym / sponsor ID
- 2014156
- Conditions
- Rotator Cuff Tears
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 31 Jan 2014 (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.
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.
Detailed description
The supraspinatus tendon is the most commonly affected tendon in rotator cuff tears. Early detection of a supraspinatus tear using an accurate physical examination is, therefore, important. However, the currently used physical tests for detecting supraspinatus tears are poor diagnostic indicators and involve a wide range of sensitivity and specificity values. Therefore, the aim of this study was to establish a new physical test for the diagnosis of supraspinatus tears and evaluate its accuracy in comparison with conventional tests.
Between November 2012 and January 2014, 200 consecutive patients undergoing shoulder arthroscopy were prospectively evaluated preoperatively. The hug-up test, empty can (EC) test, full can (FC) test, Neer impingement sign, and Hawkins-Kennedy impingement sign were used and compared statistically for their accuracy in terms of supraspinatus tears, with arthroscopic findings as the gold standard. Muscle strength was precisely quantified using an electronic digital tensiometer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P | – | Diagnostic Test: The hug-up test, Diagnostic Test: EC test, Diagnostic Test: FC test, Diagnostic Test: Neer impingement sign, Diagnostic Test: Hawkins-Kennedy impingement sign, Diagnostic Test: diagnostic arthroscopypatients suffering form shoulder pain and/or weakness or dislication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder 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 |
|---|---|---|
| The hug-up testIt is a new physical test used to detect supraspinatus tear | Diagnostic test | P |
| EC testIt is a traditional physical test used to detect supraspinatus tear | Diagnostic test | P |
| FC testIt is a traditional physical test used to detect supraspinatus tear | Diagnostic test | P |
| Neer impingement signIt is a traditional physical test used to detect supraspinatus tear | Diagnostic test | P |
| Hawkins-Kennedy impingement signIt is a traditional physical test used to detect supraspinatus tear | Diagnostic test | P |
| diagnostic arthroscopyThe 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. | Diagnostic test | P |
Primary outcome
patients' self-reported pain
Time frame: immediately after the test
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.
diagnostic arthroscopy
Time frame: during the arthrosocpic procedure
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,
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.
Yulei Liu 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?
patients' self-reported pain (time frame: immediately after the test). The study lists 2 primary outcomes in all. 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.