Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Study Overview
=================
Brief Summary
-----------------
Study population: Subjects with long standing symptoms from calcific tendonitis, non-responsive to other forms of conservative treatment Study method: A cohort of 50 patients with symptomatic calcific tendonitis will be treated by ultrasound-guided needle lavage. At baseline all study subjects will be assessed by clinical examination, imaging of the shoulder by x-ray and sonography and by the self-report section of the American Shoulder and Elbow Surgeons score (ASES). Follow-up will be performed after 1 and 4 weeks (score only), 3 (clinical, score, ultrasound, x-ray), 6 and 12 months (score only), and after 24 months (clinical, score, ultrasound, x-ray). Patients with insufficient treatment effect will be offered physiotherapy, re-lavage or surgical treatment by acromioplasty. Purpose of the study: The investigators want to find out if shoulder function, measured by a shoulder score, will increase during follow-up how much of the calcific material can be aspirated (in ml) to which extend the calcific deposit disappears on x-rays and sonographic images how many patients will need surgical treatment

Official Title
-----------------
Treatment of Calcific Tendinitis by Ultrasound-guided Needle Lavage

Conditions
-----------------
Calcific Tendinitis

Intervention / Treatment
-----------------
* Procedure: Ultrasound guided needle lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder pain for at least 6 months, localised laterally on the upper humerus Painful arc Positive Hawkins test and/or Neers tegn for impingement Calcific deposit of >= 5 mm on shoulder x-ray, verified on sonography with a localisation in the supraspinatus or infraspinatus tendon Exclusion Criteria: The presence of other local or systemic diseases affecting shoulder function like arthritis, inflammatory arthropathy or instability Symptoms from a cervical root syndrome Sonographic or MRI findings for a rotator cuff tear Earlier surgery in the study shoulder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided needle lavage<br>Ultrasound guided needle lavage | Procedure: Ultrasound guided needle lavage<br>* A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption.<br>* Other names: Barbotage;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The self-report section of the American Shoulder and Elbow Surgeons score (ASES) | The self-report section of the American Shoulder and Elbow Surgeons score (ASES) consists of two equally weighted parts for pain and shoulder function, each contributing 50 points to a maximum score of 100. Pain measurement is performed on a 10 cm visual analogue scale divided into 1 cm increments. Shoulder function is measured by classifying 10 activities of daily living on a four-point ordinal scale. Change in points on the ASES scale from baseline to 24 month follow-up is the primary outcome measure of our study. | Baseline and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who need operative treatment during follow-up |  | Baseline to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calcific tendinitis, Shoulder, Needle lavage, Ultrasound-guided