ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01602653
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Francesco Ioppolo, University of Roma La Sapienza

May 14, 2012
May 21, 2012
May 21, 2012
November 2008
June 2010   (Final data collection date for primary outcome measure)
Constant Murley Scale [ Time Frame: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. ]
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
Same as current
No Changes Posted
Visual Analogic Scale [ Time Frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention ]
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
Same as current
Not Provided
Not Provided
 
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Supraspinatus Calcifying Tendonitis
  • Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
    an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
  • Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
    an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
  • Active Comparator: 1
    the first group of patients received an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
    Intervention: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
  • Active Comparator: 2
    The second grouop of patients received 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
    Intervention: Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01602653
PTJ-2011-0252.R1
No
Not Provided
Not Provided
Francesco Ioppolo, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Not Provided
University of Roma La Sapienza
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP