Enhancement of healing after arthroscopic rotator cuff repair by extracorporeal shock wave therapy.

JRCT ID: jRCTs032200097

Registered date:27/08/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rotator cuff tear
• Date of first enrollment: 01/09/2020
• Target sample size: 150
• Study type: Interventional
• Intervention(s): After arthroscopic rotator cuff repair, ESWT is used as an intervention under general anesthesia.

Outcome(s)

• Primary Outcome: Assessment of retear by MRI findings

Secondary Outcome

1) Evaluation of pain
Numerical Rating Scale (NRS)
Consumption of analgesics
Central Sensitization Inventory (CSI)
Pain Detect
2) Evaluation of function
Japanese Orthopaedic Association (JOA) score
ASES score
Constant score
Range of motion
Muscle strength
DASH (Disability of the Arm, Shoulder, and Hand)
3) Evaluation of QOL
SF-36v2
4) Evaluation of psychology
HADS (Hospital Anxiety and Depression Scale)
5) MRI findings
Sugaya classification
Cuff repair integrity score
Goutallier classification
6) Adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Aged 20 and over
2. Patients who were diagnosed with a rotator cuff tear
3. Patients who have an arthroscopic rotator cuff repair
4. Patients who have written consent to participate in this study

Exclude criteria

1. Blood disorders, coagulation disorders or anticoagulants
2. Thrombosis
3. Malignancy
4. Acute inflammation
5. Polyneuropathy
6. Patients with skin disease in the irradiated area
7. Patients on long term cortisone therapy for more than 6 months or less than 6 weeks after the last cortisone injection
8. Pregnancy
9. Patients with contraindications to MRI
10. Patients using implantable defibrillators or pacemakers
11. Patients judged by the doctor to be unsuitable for inclusion

Related Information

• Primary Sponsor: Kamiyama Masataka
• Secondary Sponsor: Chikuda Hirotaka