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

NCT06563739 | Recruiting DMC

• 1 other identifier: M2024520
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tear

Keywords

Shock wave technique

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Active shoulder ranges of motion

  6 weeks, 3 months, and 6 months after surgery

Study Arms (8)

Exposed group1

EXPERIMENTAL

Patients who receive divergent low energy once a week

Procedure: Divergent low energy shock wave

Exposed group2

EXPERIMENTAL

Patients who receive divergent low energy twice a week

Procedure: Divergent low energy shock wave

Exposed group3

EXPERIMENTAL

Patients who recieve divergent medium and low energy once a week

Procedure: Divergent medium and low energy shock wave

Exposed group4

EXPERIMENTAL

Patients who receive divergent medium and low energy twice a week

Procedure: Divergent medium and low energy shock wave

Exposed group 5

EXPERIMENTAL

Patients who receive focused low energy once a week

Procedure: Focused low energy shock wave

Exposed group6

EXPERIMENTAL

Patients who receive divergent medium energy once a week

Procedure: Divergent medium energy shock wave

Exposed group 7

EXPERIMENTAL

Patients who receive divergent medium energy twice a week

Procedure: Divergent medium energy shock wave

Non-exposed group

EXPERIMENTAL

Patients who receive rehabilitation assessment and training guidance

Procedure: Non-exposed group

Interventions

Divergent low energy shock wave PROCEDURE

Receive divergent low energy shock wave once a week

Exposed group1

Divergent medium and low energy shock wave PROCEDURE

Receive divergent medium and low energy shock wave once a week

Exposed group3

Focused low energy shock wave PROCEDURE

Receive focused low energy shock wave once a week

Exposed group 5

Divergent medium energy shock wave PROCEDURE

Receive divergent medium energy shock wave once a week

Exposed group6

Non-exposed group PROCEDURE

Traditional rehabilitation assessment and training guidance

Non-exposed group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

PekingUTH

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Guoqing Cui

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Shuhan Zhang

CONTACT

86-15336331337; shuhan.zhang@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 21, 2024
• Study Start: May 5, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)