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

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ClinicalTrials.gov Identifier: NCT02403856
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Calcifying Tendinitis of Shoulder Drug: Sodium Chloride 0.9% Drug: Methylprednisolone acetate Procedure: Ultrasound-guided Needling and Lavage Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2015
Actual Primary Completion Date : April 2, 2017
Actual Study Completion Date : November 13, 2017


Arm Intervention/treatment
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.
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.
Other Name: NaCl 0.9%

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

Procedure: Ultrasound-guided Needling and Lavage



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Anti-inflammatory and analgesic intake [ Time Frame: 7 days ]
  2. Size of the calcific deposit [ Time Frame: 7 days ]
  3. Size of the calcific deposit [ Time Frame: 3 months ]
  4. Size of the calcific deposit [ Time Frame: 12 months ]
  5. Number of frozen shoulder in each group [ Time Frame: 7 days ]
  6. Number of frozen shoulder in each group [ Time Frame: 6 weeks ]
  7. Number of frozen shoulder in each group [ Time Frame: 3 months ]
  8. Number of frozen shoulder in each group [ Time Frame: 6 months ]
  9. Number of frozen shoulder in each group [ Time Frame: 12 months ]
  10. VAS pain during daily activity [ Time Frame: 7 days ]
  11. VAS pain during daily activity [ Time Frame: 6 weeks ]
  12. VAS pain during daily activity [ Time Frame: 3 months ]
  13. VAS pain during daily activity [ Time Frame: 6 months ]
  14. VAS pain during daily activity [ Time Frame: 12 months ]
  15. VAS pain at rest [ Time Frame: 7 days ]
  16. VAS pain at rest [ Time Frame: 6 weeks ]
  17. VAS pain at rest [ Time Frame: 3 months ]
  18. VAS pain at rest [ Time Frame: 6 months ]
  19. VAS pain at rest [ Time Frame: 12 months ]
  20. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 7 days ]
  21. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 6 weeks ]
  22. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 3 months ]
  23. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 6 months ]
  24. The Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403856


Locations
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France
La Roche sur Yon Hospital
La Roche sur Yon, France
Nantes University Hospital
Nantes, France, 44093
Rennes University hospital
Rennes, France
Sponsors and Collaborators
Nantes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02403856    
Other Study ID Numbers: RC15_0019
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Keywords provided by Nantes University Hospital:
calcifying tendinitis
Needle lavage
Shoulder
Corticosteroid injection
Ultrasound-guided
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents