Clinical trial NCT06329154: Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries
Official title: Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Rotator Cuff Injuries
Extracorporeal Shockwave Therapy
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from Baseline Visual Analogue Scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Range of Motion at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Constant-Murley Score at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Isokinetic muscle strength testing at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Magnetic resonance imaging at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Musculoskeletal ultrasound at 4 weeks
timeFrame: baseline and 4 weeks
Secondary outcomes:
measure: Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Shoulder Pain and Disability Index at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks
timeFrame: baseline and 4 weeks
measure: Change from Baseline Pittsburgh sleep quality index at 4 weeks
timeFrame: baseline and 4 weeks
Other outcomes:
Locations:
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
Study officials:
References: