Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries

Yong Liu, MD

Status: Enrolling

Conditions: Rotator Cuff Injuries

Treatments: Device: Extracorporeal shock wave therapy; Other: conventional rehabilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06329154

PJ-KS-KY-2024-03(X)

Details and patient eligibility

About

This clinical trial aims to learn about the effect of extracorporeal shock wave therapy on rotator cuff injuries. The main question it aims to answer is the efficacy of extracorporeal shock wave therapy on the improvement of pain, shoulder function, and quality of life in patients with rotator cuff injuries. The experimental group of patients received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group only received conventional rehabilitation therapy. Compare the two groups to explore the therapeutic effect of extracorporeal shock wave therapy on rotator cuff injuries.

Enrollment: 58 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria of rotator cuff injuries in 2019 American Academy of Orthopaedic Surgeons Clinical Practice Guideline for rotator Cuff Injuries (diagnostic criteria: （1）The clinical signs included positive empty cup test and full cup test, positive internal rotation resistance test in abduction and external rotation position and positive Jobe sign in lateral position. (2) Imaging: magnetic resonance imaging, magnetic resonance arthrography or ultrasound showed rotator cuff injuries, including supraspinatus, infraspinatus, teres minor and subscapularis tendon injuries);
• Definite imaging diagnosis: magnetic resonance imaging, magnetic resonance arthrography or ultrasound examination;
• The shoulder joint did not receive surgical treatment;
• Both sexes, aged 20-80 years old;
• Stable vital signs, good communication, and active cooperation to complete the relevant evaluation and treatment;
• Informed consent was obtained from patients or their families before treatment.

Exclusion criteria

• MRI showed medium, large and huge full-thickness rotator cuff tears;
• Skin damage or skin disease at the application site;
• Previous history of shoulder surgery;
• Pregnant or lactating women;
• Allergic constitution;
• Patients with primary diseases of the heart, liver, kidney, or hematopoietic system, patients with mental disorders, patients with built-in cardiac pacemaker, and patients with implanted metal medical devices;
• complicated with other diseases that cause body pain;
• Unable to cooperate with the completion of the whole treatment and follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

extracorporeal shock wave therapy group

Experimental group

Description:

The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc.

Treatment:

Device: Extracorporeal shock wave therapy

control group

Active Comparator group

Description:

The control group received conventional rehabilitation therapy. Conventional rehabilitation therapy includes medium frequency electricity, ultrasound, ultrashort wave, laser, wax therapy, etc.

Treatment:

Other: conventional rehabilitation therapy