Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection

Study Overview
=================
Brief Summary
-----------------
Calcific tendinitis of the rotator cuff is a common cause of chronic pain of the shoulder. Needling and lavage of the calcification is one of the therapeutic options after failure of conservative management with physiotherapy and anti-inflammatory drugs. Needling is usually followed by a corticosteroid injection in the subacromial bursae in order to prevent acute pain reaction due to the intervention. However, the relevance of this injection has never been proven. Moreover, corticosteroid could prevent the inflammatory reaction induced by the needling and thus the body's natural calcium resorption processes. Finally, corticosteroids could have deleterious effect on the tendon structures and favour local infection. Our hypothesis is that corticosteroid have no significant effect on acute pain after needling and therefore should not been performed systematically after needling.

Official Title
-----------------
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection: A Double Blind Controlled Study

Conditions
-----------------
Calcifying Tendinitis of Shoulder

Intervention / Treatment
-----------------
* Drug: Sodium Chloride 0.9%
* Drug: Methylprednisolone acetate
* Procedure: Ultrasound-guided Needling and Lavage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shoulder pain for at least 3 month Positive Hawkins, Yocum and/or Neer test for impingement Calcific deposit >= 5 mm on shoulder x-ray in one the tendon of the rotator cuff Exclusion Criteria: Allergy to lidocaïne or methylprednisolone acetate Acute pain suggestive of resorption of the calcification with ill-defined - calcification on X-Ray Other shoulder diseases : ostearthritis of the gleno-humeral or acromio-clavicular joint Sonographic findings of rotator cuff tear Subacromial steroid injection in the previous month Uncontrolled diabetes Pregnant women Contraindication for the use of nonsteroidal antiinflammatory drugs or paracetamol/acetaminophene

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (Sodium Chloride 0.9%)<br>Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae. | Drug: Sodium Chloride 0.9%<br>* Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.<br>* Other names: NaCl 0.9%;Procedure: Ultrasound-guided Needling and Lavage<br> <br> |
| Active Comparator: Control group (Methylprednisolone Acetate)<br>Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae | Drug: Methylprednisolone acetate<br>* Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae<br>* Other names: Dépomédrol;Procedure: Ultrasound-guided Needling and Lavage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum pain (VAS scale) | Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-inflammatory and analgesic intake |  | 7 days | 
| Size of the calcific deposit |  | 7 days | 
| Size of the calcific deposit |  | 3 months | 
| Size of the calcific deposit |  | 12 months | 
| Number of frozen shoulder in each group |  | 7 days | 
| Number of frozen shoulder in each group |  | 6 weeks | 
| Number of frozen shoulder in each group |  | 3 months | 
| Number of frozen shoulder in each group |  | 6 months | 
| Number of frozen shoulder in each group |  | 12 months | 
| VAS pain during daily activity |  | 7 days | 
| VAS pain during daily activity |  | 6 weeks | 
| VAS pain during daily activity |  | 3 months | 
| VAS pain during daily activity |  | 6 months | 
| VAS pain during daily activity |  | 12 months | 
| VAS pain at rest |  | 7 days | 
| VAS pain at rest |  | 6 weeks | 
| VAS pain at rest |  | 3 months | 
| VAS pain at rest |  | 6 months | 
| VAS pain at rest |  | 12 months | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score |  | 7 days | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score |  | 6 weeks | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score |  | 3 months | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score |  | 6 months | 
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score |  | 12 months | 

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