Rotator Cuff TearNCT06563739
Study on the Application of Shock Wave Technique After Rotator Cuff Operation
A study testing Divergent low energy shock wave, Divergent medium and low energy shock wave and Focused low energy shock wave in people with Rotator Cuff Tear, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study is a prospective cohort study and is a single-center clinical trial. The subjects of this study were patients who underwent rotator cuff repair in the Department of Sports Medicine and the Department of Rehabilitation in the Third Hospital of Beijing Medical University. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Divergent low energy shock wave, Divergent medium and low energy shock wave and Focused low energy shock wave
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2024to 30 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- A rotator cuff tear was diagnosed and surgery was required
- Able to complete cardiopulmonary exercise tests
- Able to cooperate with rehabilitation training and complete questionnaire survey
Who cannot join
- Age <17 years or age >75 years
- Previous shoulder surgery history
- Irreparable rotator cuff damage
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PekingUTH
Beijing, Beijing Municipality
Guoqing Cui, professor
About this study
Official title: Director of Rehabilitation Medicine
This study is a prospective cohort study and is a single-center clinical trial. The subjects of this study were patients who underwent rotator cuff repair in the Department of Sports Medicine and the Department of Rehabilitation in the Third Hospital of Beijing Medical University. The sample size of this study is about 2600 cases. We will collect the results of shoulder joint function score, quality of life score, pain score and MRI examination of all participants at baseline. Meanwhile, epidemiological data and related clinical characteristics of patients will be collected at the time of enrollment. All the collected data information was entered into the computer for statistical analysis, and the prognosis of patients under different programs was evaluated.
Read the detailed description
The shoulder joint is the most flexible joint in the body, and the rotator cuff is an important structure to maintain its stability, and the flexibility of the shoulder joint also leads to joint instability leading to rotator cuff tears, especially in the elderly, previous studies have shown that the incidence of rotator cuff tears in people under the age of 20 is 9.7%, and the incidence of rotator cuff tears in people over the age of 80 can reach 62%. Rotator cuff tears are a common cause of limited mobility and pain in the shoulder joint, severely affecting patients' quality of life. Young people, high-level athletes and sports enthusiasts also have a higher risk of rotator cuff injury.
Arthroscopic rotator cuff repair is widely used in the treatment of rotator cuff tears, and has many advantages such as less postoperative tissue damage, less surgical scar, less infection, and faster recovery. However, its postoperative rehabilitation has always been a hot topic of research. The basic goal of rehabilitation is to protect tendons, promote their healing, prevent shoulder stiffness and muscle atrophy.
In recent years, there have been clinical studies on the application of ESWT in arthroscopic postoperative patients, but its efficacy is still different . However, few clinical studies have been conducted to investigate the effects of ESWT on functional recovery, tendon recovery and MRI imaging after arthroscopic rotator cuff repair. In addition, currently, the application of shock wave technology in the treatment of patients after rotator cuff surgery is very confusing, and there is no clear optimal treatment plan.
In conclusion, the purpose of this study is to compare the difference in efficacy of postoperative rehabilitation programs of different ESWT combined with conventional rehabilitation training on patients after rotator cuff repair, the impact of ESWT on clinical efficacy of patients after rotator cuff repair, and to explore the application of shock wave technology for accurate diagnosis and treatment of rotator cuff surgery
- Conditions
- Rotator Cuff Tear
- Being tested
- Divergent low energy shock wave, Divergent medium and low energy shock wave, Focused low energy shock wave, Divergent medium energy shock wave, Non-exposed group
- Keywords
- Shock wave technique
- 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.
Divergent low energy shock waveProcedure or surgery
Receive divergent low energy shock wave once a week
Divergent low energy shock waveProcedure or surgery
Receive divergent low energy shock wave twice a week
Divergent medium and low energy shock waveProcedure or surgery
Receive divergent medium and low energy shock wave once a week
Divergent medium and low energy shock waveProcedure or surgery
Receive divergent medium and low energy shock wave twice a week
Focused low energy shock waveProcedure or surgery
Receive focused low energy shock wave once a week
Divergent medium energy shock waveProcedure or surgery
Receive divergent medium energy shock wave once a week
Divergent medium energy shock waveProcedure or surgery
Receive divergent medium energy shock wave twice a week
Non-exposed groupProcedure or surgery
Traditional rehabilitation assessment and training guidance
| Study group | Role | What they receive |
|---|---|---|
| Exposed group1 | Experimental | Patients who receive divergent low energy once a week Receives: Procedure: Divergent low energy shock wave |
| Exposed group2 | Experimental | Patients who receive divergent low energy twice a week Receives: Procedure: Divergent low energy shock wave |
| Exposed group3 | Experimental | Patients who recieve divergent medium and low energy once a week Receives: Procedure: Divergent medium and low energy shock wave |
| Exposed group4 | Experimental | Patients who receive divergent medium and low energy twice a week Receives: Procedure: Divergent medium and low energy shock wave |
| Exposed group 5 | Experimental | Patients who receive focused low energy once a week Receives: Procedure: Focused low energy shock wave |
| Exposed group6 | Experimental | Patients who receive divergent medium energy once a week Receives: Procedure: Divergent medium energy shock wave |
| Exposed group 7 | Experimental | Patients who receive divergent medium energy twice a week Receives: Procedure: Divergent medium energy shock wave |
| Non-exposed group | Experimental | Patients who receive rehabilitation assessment and training guidance Receives: Procedure: Non-exposed group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain VAS score
pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
Measured: 6 weeks, 3 months, and 6 months after surgery
ASES score
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
Measured: 6 weeks, 3 months, and 6 months after surgery
Secondary outcomes (1)
Active shoulder ranges of motion
internal rotation at the side, and external and internal rotation at 90° of abduction
Measured: 6 weeks, 3 months, and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start5 May 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoqing Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563739
- Sponsor's protocol ID
- M2024520
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2024
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director of Rehabilitation Medicine
- ClinicalTrials.gov ID
- NCT06563739
- Acronym / sponsor ID
- M2024520
- Conditions
- Rotator Cuff Tear
- Keywords
- Shock wave technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Aug 2024 (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.
This study is a prospective cohort study and is a single-center clinical trial. The subjects of this study were patients who underwent rotator cuff repair in the Department of Sports Medicine and the Department of Rehabilitation in the Third Hospital of Beijing Medical University. The sample size of this study is about 2600 cases. We will collect the results of shoulder joint function score, quality of life score, pain score and MRI examination of all participants at baseline. Meanwhile, epidemiological data and related clinical characteristics of patients will be collected at the time of enrollment. All the collected data information was entered into the computer for statistical analysis, and the prognosis of patients under different programs was evaluated.
Detailed description
The shoulder joint is the most flexible joint in the body, and the rotator cuff is an important structure to maintain its stability, and the flexibility of the shoulder joint also leads to joint instability leading to rotator cuff tears, especially in the elderly, previous studies have shown that the incidence of rotator cuff tears in people under the age of 20 is 9.7%, and the incidence of rotator cuff tears in people over the age of 80 can reach 62%. Rotator cuff tears are a common cause of limited mobility and pain in the shoulder joint, severely affecting patients' quality of life. Young people, high-level athletes and sports enthusiasts also have a higher risk of rotator cuff injury.
Arthroscopic rotator cuff repair is widely used in the treatment of rotator cuff tears, and has many advantages such as less postoperative tissue damage, less surgical scar, less infection, and faster recovery. However, its postoperative rehabilitation has always been a hot topic of research. The basic goal of rehabilitation is to protect tendons, promote their healing, prevent shoulder stiffness and muscle atrophy.
In recent years, there have been clinical studies on the application of ESWT in arthroscopic postoperative patients, but its efficacy is still different . However, few clinical studies have been conducted to investigate the effects of ESWT on functional recovery, tendon recovery and MRI imaging after arthroscopic rotator cuff repair. In addition, currently, the application of shock wave technology in the treatment of patients after rotator cuff surgery is very confusing, and there is no clear optimal treatment plan.
In conclusion, the purpose of this study is to compare the difference in efficacy of postoperative rehabilitation programs of different ESWT combined with conventional rehabilitation training on patients after rotator cuff repair, the impact of ESWT on clinical efficacy of patients after rotator cuff repair, and to explore the application of shock wave technology for accurate diagnosis and treatment of rotator cuff surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Exposed group1 | Experimental | Procedure: Divergent low energy shock wavePatients who receive divergent low energy once a week |
| Exposed group2 | Experimental | Procedure: Divergent low energy shock wavePatients who receive divergent low energy twice a week |
| Exposed group3 | Experimental | Procedure: Divergent medium and low energy shock wavePatients who recieve divergent medium and low energy once a week |
| Exposed group4 | Experimental | Procedure: Divergent medium and low energy shock wavePatients who receive divergent medium and low energy twice a week |
| Exposed group 5 | Experimental | Procedure: Focused low energy shock wavePatients who receive focused low energy once a week |
| Exposed group6 | Experimental | Procedure: Divergent medium energy shock wavePatients who receive divergent medium energy once a week |
| Exposed group 7 | Experimental | Procedure: Divergent medium energy shock wavePatients who receive divergent medium energy twice a week |
| Non-exposed group | Experimental | Procedure: Non-exposed groupPatients who receive rehabilitation assessment and training guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A rotator cuff tear was diagnosed and surgery was required
- Able to complete cardiopulmonary exercise tests
- Able to cooperate with rehabilitation training and complete questionnaire survey
Key exclusion criteria (3 listed)
- Age <17 years or age >75 years
- Previous shoulder surgery history
- Irreparable rotator cuff damage
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 |
|---|---|---|
| Divergent low energy shock waveReceive divergent low energy shock wave once a week | Procedure or surgery | Exposed group1 |
| Divergent low energy shock waveReceive divergent low energy shock wave twice a week | Procedure or surgery | Exposed group2 |
| Divergent medium and low energy shock waveReceive divergent medium and low energy shock wave once a week | Procedure or surgery | Exposed group3 |
| Divergent medium and low energy shock waveReceive divergent medium and low energy shock wave twice a week | Procedure or surgery | Exposed group4 |
| Focused low energy shock waveReceive focused low energy shock wave once a week | Procedure or surgery | Exposed group 5 |
| Divergent medium energy shock waveReceive divergent medium energy shock wave once a week | Procedure or surgery | Exposed group6 |
| Divergent medium energy shock waveReceive divergent medium energy shock wave twice a week | Procedure or surgery | Exposed group 7 |
| Non-exposed groupTraditional rehabilitation assessment and training guidance | Procedure or surgery | Non-exposed group |
Primary outcome
pain VAS score
Time frame: 6 weeks, 3 months, and 6 months after surgery
pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.
ASES score
Time frame: 6 weeks, 3 months, and 6 months after surgery
The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.
1 secondary outcome
Active shoulder ranges of motion
Time frame: 6 weeks, 3 months, and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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 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?
A study testing Divergent low energy shock wave, Divergent medium and low energy shock wave and Focused low energy shock wave in people with Rotator Cuff Tear, 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 3 inclusion and 3 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 21 Aug 2024. 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 Shuhan Zhang (86-15336331337, shuhan.zhang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain VAS score (time frame: 6 weeks, 3 months, and 6 months after surgery). 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 21 Aug 2024.