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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 4

Conditions: Calcifying Tendinitis of Shoulder

Treatments: Drug: Methylprednisolone acetate; Procedure: Ultrasound-guided Needling and Lavage; Drug: Sodium Chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT02403856

RC15_0019

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups

Experimental group (Sodium Chloride 0.9%)

Experimental group

Description:

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.

Treatment:

Drug: Sodium Chloride 0.9%

Procedure: Ultrasound-guided Needling and Lavage

Control group (Methylprednisolone Acetate)

Active Comparator group

Description:

Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae

Treatment:

Procedure: Ultrasound-guided Needling and Lavage

Drug: Methylprednisolone acetate