Clinical Study On Extracorporeal Shock Wave Therapy For Rotator Cuff Injuries

NCT06329154 | Recruiting

• 1 other identifier: PJ-KS-KY-2024-03(X)
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Keywords

Rotator Cuff Injuries; Extracorporeal Shockwave Therapy

Outcome Measures

Primary Outcomes (6)

• Change from Baseline Visual Analogue Scale at 4 weeks

  Visual analogue Scale is the most commonly used single-dimensional measurement of pain intensity. The scale mainly consists of a 10-cm straight line, one end of which indicates "no pain at all" and the other end indicates "the most severe pain imaginable" or "pain to the extreme" etc. The patient will be asked to mark the corresponding position on this line to represent the intensity of the pain they feel at that time.

  baseline and 4 weeks

• Change from Baseline Range of Motion at 4 weeks

  The range of motion of the shoulder joint refers to the active and passive range of motion of the shoulder joint measured with a protractor, including forward flexion, back extension, abduction, internal rotation, and external rotation.

  baseline and 4 weeks

• Change from Baseline Constant-Murley Score at 4 weeks

  Constant-Murley Score is the unified shoulder score of the European Society for Shoulder and Elbow Surgery. The left and right shoulder joints were scored separately. It mainly includes 8 aspects of shoulder joint-related problems: 1, pain; 2. Degree of influence on daily life; 3. The hand can lift the height that can be reached; 4. Upper limb abduction muscle strength; 5. The degree of upper limb forward lifting; 6, the degree of upper limb abduction; 7. The degree of external rotation of the upper limbs; 8, the degree of internal rotation of the upper limb can be achieved.

  baseline and 4 weeks

• Change from Baseline Isokinetic muscle strength testing at 4 weeks

  Isokinetic muscle testing can be used for quantitative measurement of muscle strength, and the evaluation results have objectivity, accuracy, repeatability, and high sensitivity.

  baseline and 4 weeks

• Change from Baseline Magnetic resonance imaging at 4 weeks

  Magnetic resonance imaging has good soft tissue resolution and can clearly show the injuries of tendons and ligaments around the shoulder joint. It is one of the main examination methods for the evaluation of rotator cuff injuries.

  baseline and 4 weeks

• Change from Baseline Musculoskeletal ultrasound at 4 weeks

  Musculoskeletal ultrasound uses high-frequency ultrasound to diagnose musculoskeletal diseases, which can clearly show the superficial soft tissue structures such as muscles, tendons, ligaments, peripheral nerves, and their lesions. It is one of the main examination methods for the evaluation of rotator cuff injuries.

  baseline and 4 weeks

Secondary Outcomes (5)

• Change from Baseline American Shoulder and Elbow Surgeons Score at 4 weeks

  baseline and 4 weeks

• Change from Baseline Shoulder Pain and Disability Index at 4 weeks

  baseline and 4 weeks

• Change from Baseline Disability of the Arm, Shoulder and Hand Score at 4 weeks

  baseline and 4 weeks

• Change from Baseline University of California at Los Angeles Shoulder Scale at 4 weeks

  baseline and 4 weeks

• Change from Baseline Pittsburgh sleep quality index at 4 weeks

  baseline and 4 weeks

Study Arms (2)

extracorporeal shock wave therapy group

EXPERIMENTAL

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.

Device: Extracorporeal shock wave therapy

control group

ACTIVE COMPARATOR

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

Other: conventional rehabilitation therapy

Interventions

Extracorporeal shock wave therapy 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.

extracorporeal shock wave therapy group

conventional rehabilitation therapy 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.

control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yong Liu, MD: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

yong liu

CONTACT

18098876656; fuwa52008@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessor was blinded. The assessor, who not participated in the study, was experienced, and well qualified in the use.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physcician

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 25, 2024
• Study Start: February 27, 2024
• Primary Completion: January 27, 2025
• Study Completion: February 27, 2025
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CN (1)