Study on the Application of Shock Wave Technique After Rotator Cuff Operation

NCT ID: NCT06563739

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Rotator Cuff Tear

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exposed group1

Patients who receive divergent low energy once a week

Group Type EXPERIMENTAL

Divergent low energy shock wave

Intervention Type PROCEDURE

Receive divergent low energy shock wave once a week

Exposed group2

Patients who receive divergent low energy twice a week

Group Type EXPERIMENTAL

Divergent low energy shock wave

Intervention Type PROCEDURE

Receive divergent low energy shock wave twice a week

Exposed group3

Patients who recieve divergent medium and low energy once a week

Group Type EXPERIMENTAL

Divergent medium and low energy shock wave

Intervention Type PROCEDURE

Receive divergent medium and low energy shock wave once a week

Exposed group4

Patients who receive divergent medium and low energy twice a week

Group Type EXPERIMENTAL

Divergent medium and low energy shock wave

Intervention Type PROCEDURE

Receive divergent medium and low energy shock wave twice a week

Exposed group 5

Patients who receive focused low energy once a week

Group Type EXPERIMENTAL

Focused low energy shock wave

Intervention Type PROCEDURE

Receive focused low energy shock wave once a week

Exposed group6

Patients who receive divergent medium energy once a week

Group Type EXPERIMENTAL

Divergent medium energy shock wave

Intervention Type PROCEDURE

Receive divergent medium energy shock wave once a week

Exposed group 7

Patients who receive divergent medium energy twice a week

Group Type EXPERIMENTAL

Divergent medium energy shock wave

Intervention Type PROCEDURE

Receive divergent medium energy shock wave twice a week

Non-exposed group

Patients who receive rehabilitation assessment and training guidance

Group Type EXPERIMENTAL

Non-exposed group

Intervention Type PROCEDURE

Traditional rehabilitation assessment and training guidance

Interventions

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Divergent low energy shock wave

Receive divergent low energy shock wave once a week

Intervention Type PROCEDURE

Divergent low energy shock wave

Receive divergent low energy shock wave twice a week

Intervention Type PROCEDURE

Divergent medium and low energy shock wave

Receive divergent medium and low energy shock wave once a week

Intervention Type PROCEDURE

Divergent medium and low energy shock wave

Receive divergent medium and low energy shock wave twice a week

Intervention Type PROCEDURE

Focused low energy shock wave

Receive focused low energy shock wave once a week

Intervention Type PROCEDURE

Divergent medium energy shock wave

Receive divergent medium energy shock wave once a week

Intervention Type PROCEDURE

Divergent medium energy shock wave

Receive divergent medium energy shock wave twice a week

Intervention Type PROCEDURE

Non-exposed group

Traditional rehabilitation assessment and training guidance

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. A rotator cuff tear was diagnosed and surgery was required
2. Able to complete cardiopulmonary exercise tests
3. Able to cooperate with rehabilitation training and complete questionnaire survey

Exclusion Criteria

1. Age \<17 years or age \>75 years
2. Previous shoulder surgery history
3. Irreparable rotator cuff damage
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guoqing Cui

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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PekingUTH

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuhan Zhang

Role: CONTACT

86-15336331337

Facility Contacts

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Guoqing Cui, professor

Role: primary

Other Identifiers

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M2024520

Identifier Type: -

Identifier Source: org_study_id

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