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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Supraspinatus Calcifying Tendonitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Intervention Type DEVICE

an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.

2

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

Group Type ACTIVE_COMPARATOR

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Intervention Type DEVICE

an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.

Interventions

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Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.

Intervention Type DEVICE

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes