Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels
This study has been completed.
Sponsor:
University of Roma La Sapienza
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
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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
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 |
Additional relevant MeSH terms:
|
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013