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

Peking University

Status: Enrolling

Conditions: Rotator Cuff Tear

Treatments: Procedure: Divergent medium and low energy shock wave; Procedure: Divergent low energy shock wave; Procedure: Non-exposed group; Procedure: Divergent medium energy shock wave; Procedure: Focused low energy shock wave

Study type: Interventional

Funder types: Other

Identifiers

NCT06563739

M2024520

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 8 patient groups

Exposed group1

Experimental group

Description:

Patients who receive divergent low energy once a week

Treatment:

Procedure: Divergent low energy shock wave

Procedure: Divergent low energy shock wave

Exposed group2

Experimental group

Description:

Patients who receive divergent low energy twice a week

Treatment:

Procedure: Divergent low energy shock wave

Procedure: Divergent low energy shock wave

Exposed group3

Experimental group

Description:

Patients who recieve divergent medium and low energy once a week

Treatment:

Procedure: Divergent medium and low energy shock wave

Procedure: Divergent medium and low energy shock wave

Exposed group4

Experimental group

Description:

Patients who receive divergent medium and low energy twice a week

Treatment:

Procedure: Divergent medium and low energy shock wave

Procedure: Divergent medium and low energy shock wave

Exposed group 5

Experimental group

Description:

Patients who receive focused low energy once a week

Treatment:

Procedure: Focused low energy shock wave

Exposed group6

Experimental group

Description:

Patients who receive divergent medium energy once a week

Treatment:

Procedure: Divergent medium energy shock wave

Procedure: Divergent medium energy shock wave

Exposed group 7

Experimental group

Description:

Patients who receive divergent medium energy twice a week

Treatment:

Procedure: Divergent medium energy shock wave

Procedure: Divergent medium energy shock wave

Non-exposed group

Experimental group

Description:

Patients who receive rehabilitation assessment and training guidance

Treatment:

Procedure: Non-exposed group