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

Study Overview
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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.

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

Conditions
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Supraspinatus Calcifying Tendonitis

Intervention / Treatment
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* Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
* Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks. | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK<br>* an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.<br>|
| Active Comparator: 2<br>The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks. | Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK<br>* an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley Scale | Constant-Murley scale is the scoring system used to assess shoulder function in four of the studies being reviewed. It combines physical examination tests with subjective evaluations by the patients and consists of 35 points and 65 points respectively. Its strength is the method of its application, which is quite clearly described, and its being an improvement on pre-existing scales | Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale | It is a horizontal line, 10 cm in length with 0 cm labeled no pain and 10 cm labeled worst pain I have ever had. The patient marks on the line the point that they feel represents their perception of their current state | The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention |