Rotator Cuff TearNCT06587009
Application of Shock Wave Technique in Conservative Treatment of Rotator Cuff Tear
A study testing Shock wave therapy and Conventional conservative treatment 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. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Shock wave therapy and Conventional conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2024to 30 Dec 2025
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Identify patients with rotator cuff tears and choose conservative treatment
- Able to complete cardiopulmonary exercise tests
- Able to cooperate with rehabilitation training and complete questionnaire survey
Who cannot join
- Previous shoulder surgery history
- Irreparable rotator cuff damage
- Retear after ARCR
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. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.
Read the detailed description
A single-center randomized controlled clinical trial was conducted to compare the effect of ESWT combined with conventional rehabilitation training on patients with rotator cuff tear. To explore the effect of ESWT on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. It provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of ESWT.
- Conditions
- Rotator Cuff Tear
- Being tested
- Shock wave therapy, Conventional conservative treatment
- Keywords
- Shock wave technique, Conservative treatment
- 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.
Shock wave therapyProcedure or surgery
Received shock wave therapy 7 times a week and functional exercise therapy intervention
Conventional conservative treatmentProcedure or surgery
Conventional conservative treatment and functional exercise were given
| Study group | Role | What they receive |
|---|---|---|
| ESWT group | Experimental | Patients who receive shock wave technique Receives: Procedure: Shock wave therapy |
| Control group | Experimental | Patients who receive conventional conservative treatment Receives: Procedure: Conventional conservative treatment |
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
MRI evaluation
Through MRI qualitative and quantitative analysis, evaluate the tendon healing status after rotator cuff repair surgery.
Measured: 3 months and 6 month after surgery
UCLA score
The UCLA Shoulder Score combines input from both the physician and the patient and totals range from 0 to 35, 0s indicating worse shoulder function and 35s indicating better shoulder function outcomes.
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 posted19 Sep 2024
- Study start5 May 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (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
- 22 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
- NCT06587009
- Sponsor's protocol ID
- M2024208
- Status last verified
- Jul 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Director of Rehabilitation Medicine
- ClinicalTrials.gov ID
- NCT06587009
- Acronym / sponsor ID
- M2024208
- Conditions
- Rotator Cuff Tear
- Keywords
- Shock wave technique, Conservative treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Sep 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. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.
Detailed description
A single-center randomized controlled clinical trial was conducted to compare the effect of ESWT combined with conventional rehabilitation training on patients with rotator cuff tear. To explore the effect of ESWT on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. It provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of ESWT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT group | Experimental | Procedure: Shock wave therapyPatients who receive shock wave technique |
| Control group | Experimental | Procedure: Conventional conservative treatmentPatients who receive conventional conservative treatment |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Identify patients with rotator cuff tears and choose conservative treatment
- Able to complete cardiopulmonary exercise tests
- Able to cooperate with rehabilitation training and complete questionnaire survey
Key exclusion criteria (3 listed)
- Previous shoulder surgery history
- Irreparable rotator cuff damage
- Retear after ARCR
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 |
|---|---|---|
| Shock wave therapyReceived shock wave therapy 7 times a week and functional exercise therapy intervention | Procedure or surgery | ESWT group |
| Conventional conservative treatmentConventional conservative treatment and functional exercise were given | Procedure or surgery | Control 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.
MRI evaluation
Time frame: 3 months and 6 month after surgery
Through MRI qualitative and quantitative analysis, evaluate the tendon healing status after rotator cuff repair surgery.
UCLA score
Time frame: 6 weeks, 3 months and 6 months after surgery
The UCLA Shoulder Score combines input from both the physician and the patient and totals range from 0 to 35, 0s indicating worse shoulder function and 35s indicating better shoulder function outcomes.
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 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tear
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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 Shock wave therapy and Conventional conservative treatment 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 19 Sep 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 Amila Kuati (17888810849, amilakuati@outlook.com), 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 4 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 19 Sep 2024.