Back to resultsExtracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Primary Purpose
Supraspinatus Calcifying Tendonitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Sponsored by
About this trial
This is an interventional treatment trial for Supraspinatus Calcifying Tendonitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01602653
First Posted
May 14, 2012
Last Updated
May 18, 2012
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT01602653
Brief Title
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Official Title
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Calcifying Tendonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
Arm Title
2
Arm Type
Active Comparator
Arm Description
The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Intervention Description
an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
Intervention Description
an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Constant Murley Scale
Description
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
Time Frame
Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint.
Secondary Outcome Measure Information:
Title
Visual Analogic Scale
Description
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
Time Frame
The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
22745199
Citation
Ioppolo F, Tattoli M, Di Sante L, Attanasi C, Venditto T, Servidio M, Cacchio A, Santilli V. Extracorporeal shock-wave therapy for supraspinatus calcifying tendinitis: a randomized clinical trial comparing two different energy levels. Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
Results Reference
derived
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Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
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