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

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.

Study Overview

• Status: Recruiting
• Conditions: Rotator Cuff Tear
• Intervention / Treatment: Procedure: Divergent low energy shock wave; Procedure: Divergent low energy shock wave; Procedure: Divergent medium and low energy shock wave; Procedure: Divergent medium and low energy shock wave; Procedure: Focused low energy shock wave; Procedure: Divergent medium energy shock wave; Procedure: Divergent medium energy shock wave; Procedure: Non-exposed group

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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shuhan Zhang; Phone Number: 86-15336331337; Email: shuhan.zhang@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • PekingUTH
      • Contact: Guoqing Cui, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposed group1; Patients who receive divergent low energy once a week	Procedure: Divergent low energy shock wave; Receive divergent low energy shock wave once a week; Procedure: Divergent low energy shock wave; Receive divergent low energy shock wave twice a week
Experimental: Exposed group2; Patients who receive divergent low energy twice a week	Procedure: Divergent low energy shock wave; Receive divergent low energy shock wave once a week; Procedure: Divergent low energy shock wave; Receive divergent low energy shock wave twice a week
Experimental: Exposed group3; Patients who recieve divergent medium and low energy once a week	Procedure: Divergent medium and low energy shock wave; Receive divergent medium and low energy shock wave once a week; Procedure: Divergent medium and low energy shock wave; Receive divergent medium and low energy shock wave twice a week
Experimental: Exposed group4; Patients who receive divergent medium and low energy twice a week	Procedure: Divergent medium and low energy shock wave; Receive divergent medium and low energy shock wave once a week; Procedure: Divergent medium and low energy shock wave; Receive divergent medium and low energy shock wave twice a week
Experimental: Exposed group 5; Patients who receive focused low energy once a week	Procedure: Focused low energy shock wave; Receive focused low energy shock wave once a week
Experimental: Exposed group6; Patients who receive divergent medium energy once a week	Procedure: Divergent medium energy shock wave; Receive divergent medium energy shock wave once a week; Procedure: Divergent medium energy shock wave; Receive divergent medium energy shock wave twice a week
Experimental: Exposed group 7; Patients who receive divergent medium energy twice a week	Procedure: Divergent medium energy shock wave; Receive divergent medium energy shock wave once a week; Procedure: Divergent medium energy shock wave; Receive divergent medium energy shock wave twice a week
Experimental: Non-exposed group; Patients who receive rehabilitation assessment and training guidance	Procedure: Non-exposed group; Traditional rehabilitation assessment and training guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain VAS score	pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.	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.	6 weeks, 3 months, and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Active shoulder ranges of motion	internal rotation at the side, and external and internal rotation at 90° of abduction	6 weeks, 3 months, and 6 months after surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Guoqing Cui, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Shock wave technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: M2024520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No