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

ConditionRotator Cuff Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <17 years or age >75 years

Previous shoulder surgery history

Irreparable rotator cuff damage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Divergent low energy shock wave

    Procedure/Surgery

    Receive divergent low energy shock wave once a week

  • Divergent low energy shock wave

    Procedure/Surgery

    Receive divergent low energy shock wave twice a week

  • Divergent medium and low energy shock wave

    Procedure/Surgery

    Receive divergent medium and low energy shock wave once a week

  • Divergent medium and low energy shock wave

    Procedure/Surgery

    Receive divergent medium and low energy shock wave twice a week

  • Focused low energy shock wave

    Procedure/Surgery

    Receive focused low energy shock wave once a week

  • Divergent medium energy shock wave

    Procedure/Surgery

    Receive divergent medium energy shock wave once a week

  • Divergent medium energy shock wave

    Procedure/Surgery

    Receive divergent medium energy shock wave twice a week

  • Non-exposed group

    Procedure/Surgery

    Traditional rehabilitation assessment and training guidance

Treatment groups

70 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Exposed group1Experimental treatment 1 intervention
Group B: Exposed group2Experimental treatment 1 intervention
Group C: Exposed group3Experimental treatment 1 intervention
Group D: Exposed group4Experimental treatment 1 intervention
Group E: Exposed group 5Experimental treatment 1 intervention
Group F: Exposed group6Experimental treatment 1 intervention
Group G: Exposed group 7Experimental treatment 1 intervention
Group H: Non-exposed groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pain VAS score

pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

Time frame
6 weeks, 3 months, and 6 months after surgery
2

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.

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

Secondary outcomes

1

Active shoulder ranges of motion

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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