Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
- Conditions
- Calcifying Tendinitis of Shoulder
- Interventions
- Procedure: Ultrasound-guided Needling and Lavage
- Registration Number
- NCT02403856
- Lead Sponsor
- Nantes University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group (Sodium Chloride 0.9%) Sodium Chloride 0.9% 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. Experimental group (Sodium Chloride 0.9%) Ultrasound-guided Needling and Lavage 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. Control group (Methylprednisolone Acetate) Methylprednisolone acetate Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae Control group (Methylprednisolone Acetate) Ultrasound-guided Needling and Lavage Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
- Primary Outcome Measures
Name Time Method Maximum pain (VAS scale) 7 days Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.
- Secondary Outcome Measures
Name Time Method Anti-inflammatory and analgesic intake 7 days Size of the calcific deposit 12 months Number of frozen shoulder in each group 12 months VAS pain during daily activity 12 months VAS pain at rest 12 months The Disabilities of the Arm, Shoulder and Hand (DASH) Score 12 months
Trial Locations
- Locations (3)
Nantes University Hospital
🇫🇷Nantes, France
La Roche sur Yon Hospital
🇫🇷La Roche sur Yon, France
Rennes University hospital
🇫🇷Rennes, France