Rotator Cuff InjuryNCT04461522
Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided Injection
An observational study of Rotator Cuff Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment fails to improve pain symptoms and range of motion, the surgical indications are. Numerous studies have shown that the pain of rotator cuff injury usually comes not from the broken tendon, but from periarthritis tendonitis… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Ultrasound-guided drug injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2020to 31 Dec 2021
- How long will I take part?
- 12 Months
- 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: He was admitted to the third hospital of Peking University due to the dysfunction of shoulder joint caused by rotator cuff injury
Who may be able to join
- Chief complaint around shoulder joint discomfort or restricted movement
- Nuclear magnetic or ultrasound in the diagnosis of rotator cuff injury and not to consider surgery patients
- Assessed by the musculoskeletal ultrasound images, diagnosed with tendonitis around shoulder joint, slippery bursa phlogistic or adhesive shoulder level
- Section capsule, such as indications of patients treated with ultrasound guided by injection.
Who cannot join
- History of shoulder fractures, open trauma, or surgery combined with shoulder and hand syndrome, gout, autoimmune arthritis, infectious arthritis, and other factors resulting in shoulder pain or limited mobility
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Mouwang Zhou, Doctor, 13910092892, zhoumouwang@163.com
About this study
Official title: Prospective Cohort Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided
Rotator cuff injury is a common shoulder joint disease in clinic. If conservative treatment fails to improve pain symptoms and range of motion, the surgical indications are. Numerous studies have shown that the pain of rotator cuff injury usually comes not from the broken tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc. Ultrasound-guided drug injection combined with conventional rehabilitation treatment can significantly improve the pain symptoms and increase joint mobility. This study intends to use prospective cohort study methods, exposed factors for ultrasound-guided injection drug treatment, establish a rotator cuff injury exposure group and the control group of shoulder joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the shoulder joint function analysis, and explore for the rotator cuff injury method provides the basis of the evidence-based conservative treatment. The establishment of a conservative treatment cohort for rotator cuff injury will also lay the foundation for the accurate rehabilitation treatment of rotator cuff injury.
- Conditions
- Rotator Cuff Injury
- Being tested
- Ultrasound-guided drug injection
- Keywords
- rotator cuff injury, Ultrasound-guided drug injection
- 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.
Ultrasound-guided drug injectionProcedure or surgery
The injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Not described Receives: Procedure: Ultrasound-guided drug injection | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function
VAS
Measured: Beginning
Shoulder function
VAS
Measured: 1 week
Shoulder function
VAS
Measured: 1 month
Shoulder function
VAS
Measured: 3months
Shoulder function
VAS
Measured: 6 months
Shoulder function
ROM
Measured: Beginning
Shoulder function
ROM
Measured: 1 week
Shoulder function
ROM
Measured: 1 month
Shoulder function
ROM
Measured: 3months
Shoulder function
ROM
Measured: 6 months
Shoulder function
Constant Test
Measured: Beginning
Shoulder function
Constant Test
Measured: 1 week
Shoulder function
Constant Test
Measured: 1 month
Shoulder function
Constant Test
Measured: 3months
Shoulder function
Constant Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start10 Mar 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461522
- Sponsor's protocol ID
- M20191203
- Status last verified
- Jul 2020
- First submitted
- 7 May 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on the Outcome of Treatment of Rotator Cuff Injury by Ultrasound-guided
- ClinicalTrials.gov ID
- NCT04461522
- Acronym / sponsor ID
- M20191203
- Conditions
- Rotator Cuff Injury
- Keywords
- rotator cuff injury, Ultrasound-guided drug injection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Jul 2020 (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 shoulder joint disease in clinic. If conservative treatment fails to improve pain symptoms and range of motion, the surgical indications are. Numerous studies have shown that the pain of rotator cuff injury usually comes not from the broken tendon, but from periarthritis tendonitis, bursitis or adhesive shoulder capsule, etc. Ultrasound-guided drug injection combined with conventional rehabilitation treatment can significantly improve the pain symptoms and increase joint mobility. This study intends to use prospective cohort study methods, exposed factors for ultrasound-guided injection drug treatment, establish a rotator cuff injury exposure group and the control group of shoulder joint dysfunction queue, whether of ultrasound guided drug injection therapy can increase the shoulder joint function analysis, and explore for the rotator cuff injury method provides the basis of the evidence-based conservative treatment. The establishment of a conservative treatment cohort for rotator cuff injury will also lay the foundation for the accurate rehabilitation treatment of rotator cuff injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Procedure: Ultrasound-guided drug injection |
| Control group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- He was admitted to the third hospital of Peking University due to the dysfunction of shoulder joint caused by rotator cuff injury
Key inclusion criteria (4 listed)
- Chief complaint around shoulder joint discomfort or restricted movement
- Nuclear magnetic or ultrasound in the diagnosis of rotator cuff injury and not to consider surgery patients
- Assessed by the musculoskeletal ultrasound images, diagnosed with tendonitis around shoulder joint, slippery bursa phlogistic or adhesive shoulder level
- Section capsule, such as indications of patients treated with ultrasound guided by injection.
Key exclusion criteria (1 listed)
- History of shoulder fractures, open trauma, or surgery combined with shoulder and hand syndrome, gout, autoimmune arthritis, infectious arthritis, and other factors resulting in shoulder pain or limited mobility
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 |
|---|---|---|
| Ultrasound-guided drug injectionThe injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc. | Procedure or surgery | Exposed group |
Primary outcome
Shoulder function
Time frame: Beginning
VAS
Shoulder function
Time frame: 1 week
VAS
Shoulder function
Time frame: 1 month
VAS
Shoulder function
Time frame: 3months
VAS
Shoulder function
Time frame: 6 months
VAS
Shoulder function
Time frame: Beginning
ROM
Shoulder function
Time frame: 1 week
ROM
Shoulder function
Time frame: 1 month
ROM
Shoulder function
Time frame: 3months
ROM
Shoulder function
Time frame: 6 months
ROM
Shoulder function
Time frame: Beginning
Constant Test
Shoulder function
Time frame: 1 week
Constant Test
Shoulder function
Time frame: 1 month
Constant Test
Shoulder function
Time frame: 3months
Constant Test
Shoulder function
Time frame: 6 months
Constant Test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
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 Injury, 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 4 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 8 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mouwang Zhou, Doctor (13910092892, zhoumouwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder function (time frame: Beginning). The study lists 15 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 2020.