Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries

NCT ID: NCT06329154

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-27
• Study Completion Date: 2025-02-27

Brief Summary

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.

Conditions

Rotator Cuff Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

extracorporeal shock wave therapy group

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.

Group Type: EXPERIMENTAL

Extracorporeal shock wave therapy

Intervention Type: DEVICE

The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group was only given conventional rehabilitation therapy. According to the patient's tolerance and the specific condition, extracorporeal shock wave therapy was performed twice a week, 2000-3000 times each time, energy parameters of 2.5-3.5Bar, 8-15Hz, treatment interval \> 1 day, consecutive 4 weeks. Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser and wax therapy. Routine rehabilitation was given once a day, 5 times a week for 4 weeks.

control group

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

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation therapy

Intervention Type: OTHER

Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser, and wax therapy (same as the control group). Routine rehabilitation was given once a day, 5 times a week for 4 weeks.

Interventions

Extracorporeal shock wave therapy

The experimental group received extracorporeal shock wave therapy combined with conventional rehabilitation therapy. The control group was only given conventional rehabilitation therapy. According to the patient's tolerance and the specific condition, extracorporeal shock wave therapy was performed twice a week, 2000-3000 times each time, energy parameters of 2.5-3.5Bar, 8-15Hz, treatment interval \> 1 day, consecutive 4 weeks. Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser and wax therapy. Routine rehabilitation was given once a day, 5 times a week for 4 weeks.

Intervention Type: DEVICE

conventional rehabilitation therapy

Conventional rehabilitation therapy included medium frequency electricity, ultrasound, ultrashort wave, laser, and wax therapy (same as the control group). Routine rehabilitation was given once a day, 5 times a week for 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yong Liu, MD

OTHER

Sponsor Role: lead

Responsible Party

Yong Liu, MD

chief physcician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

yong liu

Role: CONTACT

fuwa52008@126.com

18098876656

Facility Contacts

yong liu

Role: primary

fuwa52008@126.com

18098876656

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id