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
Overview
- Phase
- Phase 4
- Intervention
- Sodium Chloride 0.9%
- Conditions
- Calcifying Tendinitis of Shoulder
- Sponsor
- Nantes University Hospital
- Enrollment
- 136
- Locations
- 3
- Primary Endpoint
- Maximum pain (VAS scale)
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
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
Arms & Interventions
Experimental group (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.
Intervention: Sodium Chloride 0.9%
Experimental group (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.
Intervention: Ultrasound-guided Needling and Lavage
Control group (Methylprednisolone Acetate)
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Intervention: Methylprednisolone acetate
Control group (Methylprednisolone Acetate)
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Intervention: Ultrasound-guided Needling and Lavage
Outcomes
Primary Outcomes
Maximum pain (VAS scale)
Time Frame: 7 days
Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.
Secondary Outcomes
- Size of the calcific deposit(12 months)
- Number of frozen shoulder in each group(12 months)
- Anti-inflammatory and analgesic intake(7 days)
- 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)