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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2, 2017

Interventions

  • Drug: 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.
  • Drug: Methylprednisolone acetate
    • Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
  • Procedure: Ultrasound-guided Needling and Lavage

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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