Rotator Cuff InjuryNCT04973995
Research on Optimization of Rotator Cuff Injury Diagnosis Plan
An observational study of Rotator Cuff Injury, run by Peking University Third Hospital.
Trial summary
Rotator cuff injury is a common cause of shoulder pain and dysfunction. Finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- several physical examinations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Jun 2023
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with shoulder pain who were treated at peking university's Third Hospital outpatient clinic for a continuous period of time
Who may be able to join
- Patients who are prepared to undergo arthroscopic surgery for shoulder injuries
Who cannot join
- Shoulder stiffness, shoulder instability, calcified tendinitis, past surgery, side-to-shoulder disease, hamada osteoarthritis, frozen shoulder, acute joint injury, rheumatoid arthritis, hyperuricemia
Trial locations and contacts
No sites are listed yet.
About this study
Rotator cuff injury is a common cause of shoulder pain and dysfunction. Finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.
How to apply multiple physical examination programs to make judgments sensitively, efficiently and accurately is a clinical problem that needs to be solved urgently.
Read the detailed description
Rotator cuff injury is a common cause of shoulder pain and dysfunction. The common symptoms of rotator cuff injury include shoulder pain, weakness, and limited mobility. Arthroscopic exploration is the gold standard for the diagnosis of rotator cuff injury, but it is an invasive examination that is difficult to carry out routinely; MRI is sensitive in diagnosing rotator cuff tears Both sex and specificity are high, but due to the popularity, cost and waiting time, it is difficult to be used as a routine screening method.
Therefore, finding patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assisting in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.
However, although there are many physical examination methods for the shoulder joint, the accuracy of each method is different, and each has its own sensitivity and specificity. How to apply multiple examination programs in combination to make it sensitive, efficient and accurate Judgment is a problem that needs to be solved clinically.
This study is expected to adopt prospective research methods to collect and collect patient medical records, preoperative physical examination results, imaging data, and findings during intraoperative exploration, to understand the impact of various shoulder joint physical examination methods and imaging data on rotator cuff injuries
- Conditions
- Rotator Cuff Injury
- Being tested
- several physical examinations
- Keywords
- physical examination, Rotator cuff, LHBT
- 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.
several physical examinationsBehavioural
By using physical examinations, the incidence of these physical examinations corresponding to shoulder muscls injury
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder pain who received ER lag sign | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received External rotation resistence strength test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received Patte's test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received Errsair test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received speed test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received Yergason test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received backward traction test | Not described Receives: Behavioral: several physical examinations | |
| Patients with shoulder pain who received Cui's test | Not described Receives: Behavioral: several physical examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Accuracy of different physical examinations
After apply these physical examinations, by using Arthroscopic examination find the accuracy of these physical examinations
Measured: 1week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973995
- Sponsor's protocol ID
- M2021099
- Status last verified
- Jul 2021
- First submitted
- 21 Jul 2021
- Last updated
- 22 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 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Optimization of Rotator Cuff Injury Diagnosis Plan
- ClinicalTrials.gov ID
- NCT04973995
- Acronym / sponsor ID
- M2021099
- Conditions
- Rotator Cuff Injury
- Keywords
- physical examination, Rotator cuff, LHBT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 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.
Rotator cuff injury is a common cause of shoulder pain and dysfunction. Finding out patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assists in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.
How to apply multiple physical examination programs to make judgments sensitively, efficiently and accurately is a clinical problem that needs to be solved urgently.
Detailed description
Rotator cuff injury is a common cause of shoulder pain and dysfunction. The common symptoms of rotator cuff injury include shoulder pain, weakness, and limited mobility. Arthroscopic exploration is the gold standard for the diagnosis of rotator cuff injury, but it is an invasive examination that is difficult to carry out routinely; MRI is sensitive in diagnosing rotator cuff tears Both sex and specificity are high, but due to the popularity, cost and waiting time, it is difficult to be used as a routine screening method.
Therefore, finding patients with suspected rotator cuff injuries through physical examination of the shoulder joints, MRI further assisting in the diagnosis, and final surgical diagnosis and treatment are the current standardized procedures.
However, although there are many physical examination methods for the shoulder joint, the accuracy of each method is different, and each has its own sensitivity and specificity. How to apply multiple examination programs in combination to make it sensitive, efficient and accurate Judgment is a problem that needs to be solved clinically.
This study is expected to adopt prospective research methods to collect and collect patient medical records, preoperative physical examination results, imaging data, and findings during intraoperative exploration, to understand the impact of various shoulder joint physical examination methods and imaging data on rotator cuff injuries
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder pain who received ER lag sign | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received External rotation resistence strength test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received Patte's test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received Errsair test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received speed test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received Yergason test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received backward traction test | – | Behavioral: several physical examinations |
| Patients with shoulder pain who received Cui's test | – | Behavioral: several physical examinations |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with shoulder pain who were treated at peking university's Third Hospital outpatient clinic for a continuous period of time
Key inclusion criteria (1 listed)
- Patients who are prepared to undergo arthroscopic surgery for shoulder injuries
Key exclusion criteria (1 listed)
- Shoulder stiffness, shoulder instability, calcified tendinitis, past surgery, side-to-shoulder disease, hamada osteoarthritis, frozen shoulder, acute joint injury, rheumatoid arthritis, hyperuricemia
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 |
|---|---|---|
| several physical examinationsBy using physical examinations, the incidence of these physical examinations corresponding to shoulder muscls injury | Behavioural | Patients with shoulder pain who received Cui's test, Patients with shoulder pain who received ER lag sign, Patients with shoulder pain who received Errsair test, Patients with shoulder pain who received External rotation resistence strength test, Patients with shoulder pain who received Patte's test, Patients with shoulder pain who received Yergason test, Patients with shoulder pain who received backward traction test, Patients with shoulder pain who received speed test |
Primary outcome
the Accuracy of different physical examinations
Time frame: 1week
After apply these physical examinations, by using Arthroscopic examination find the accuracy of these physical examinations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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, MD study director
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Injury, run by Peking University Third Hospital.
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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoqing Cui, MD (15611908685, cgq3019@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Accuracy of different physical examinations (time frame: 1week). 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 22 Jul 2021.