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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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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

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.

Condition or disease Intervention/treatment Phase
Supraspinatus Calcifying Tendonitis Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: 1
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
an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.

Active Comparator: 2
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
an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Ioppolo, MD, PhD, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01602653     History of Changes
Other Study ID Numbers: PTJ-2011-0252.R1
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: May 21, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries