eedle aspiration of calcific deposits versus Shock Wave Therapy for conservative therapy resistant calcifying tendinitis of the shoulder. A Randomized Controlled Trial

Completed

Conditions: Calcific tendinitis of the shoulder
calcific deposits
10043237

Registration Number: NL-OMON49558

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

* age >18 years
• calcifications on conventional x-rays
O type I and II calcifications according to the Gärtner classification.
O minimal diameter 10 mm on AP view
• able and willing to comply to study protocol

Exclusion Criteria

* clinical signs of a frozen shoulder or adhesive capsulitis
• operations of the affected shoulder in medical history
* ESWT or NACD tretament during the last 6 months
• full-thickness lesion of the rotator cuff tendon(s) on sonography
• clinical and radiological signs of acute subacromial bursitis
• clinical and radiological signs of acromioclavicular osteoarthritis
• Rheumatic Arthritis or fibromyalgia
• any contra-indications for the specific treatments (e.g. coagulopathies, malignancies in treated area)
• other intra articular pathology: cartilage lesions, biceps pathology.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the between group differences in functional outcome<br /><br>(measured with the Constant-Murley Score) between baseline and 12 months<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. to assess the cost-effectiveness of both interventions over a period of 12<br /><br>months.<br /><br>2. to assess between group differences in change in pain scores, quality of<br /><br>life, adverse events and use of medications between baseline and 12 months<br /><br>follow-up. </p><br>