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Completed

NCT Number: NCT01602653

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.

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Key information

Conditions

Supraspinatus Calcifying Tendonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK

Device

an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 21, 2012
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.