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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Francesco Ioppolo, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01602653
First received: May 14, 2012
Last updated: May 18, 2012
Last verified: May 2012
  Purpose

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 Intervention
Supraspinatus Calcifying Tendonitis
Device: Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Constant Murley Scale [ Time Frame: Change in the mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. ] [ Designated as safety issue: No ]
    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 [ Time Frame: The change in the mean Visual Analogic Scale scores from baseline to 3 and 6 months after the intervention ] [ Designated as safety issue: No ]
    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


Enrollment: 46
Study Start Date: November 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of Roma La Sapienza

Additional 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
Study First Received: May 14, 2012
Last Updated: May 18, 2012
Health Authority: Italy: The Italian Medicines Agency

ClinicalTrials.gov processed this record on October 30, 2014