Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels

University of Roma La Sapienza

Status: Completed

Conditions: Supraspinatus Calcifying Tendonitis

Treatments: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Study type: Interventional

Funder types: Other

Identifiers

NCT01602653

PTJ-2011-0252.R1

Details and patient eligibility

About

The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• no visible clinical benefits by previous conservative treatment
• medium and large calcific deposits, according to Bosworth classification
• type I and II Gartner deposits

Exclusion criteria

• presence of tiny calcific deposits, according to Bosworth classification
• type III, according to the Gartner classification
• age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

46 participants in 2 patient groups

1

Active Comparator group

Description:

the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.

Treatment:

Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

2

Active Comparator group

Description:

The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.

Treatment:

Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK