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NCT Number: NCT06563739

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PekingUTH

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Guoqing Cui, professor

CONTACT

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Age <17 years or age >75 years
  • Previous shoulder surgery history
  • Irreparable rotator cuff damage

Treatment and study plan

Divergent low energy shock wave

Procedure

Receive divergent low energy shock wave once a week

Divergent medium and low energy shock wave

Procedure

Receive divergent medium and low energy shock wave once a week

Focused low energy shock wave

Procedure

Receive focused low energy shock wave once a week

Divergent medium energy shock wave

Procedure

Receive divergent medium energy shock wave once a week

Non-exposed group

Procedure

Traditional rehabilitation assessment and training guidance

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Active shoulder ranges of motion

    Time frame: 6 weeks, 3 months, and 6 months after surgery

    internal rotation at the side, and external and internal rotation at 90° of abduction

Study contacts

Contact information is provided by the study sponsor or research team.

Shuhan Zhang

CONTACT

[email protected]

86-15336331337

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Director of Rehabilitation Medicine

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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