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NCT Number: NCT02403856

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

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.

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Key information

Conditions

Calcifying Tendinitis of Shoulder Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Rotator Cuff Tear Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

La Roche sur Yon Hospital, La Roche-sur-Yon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium chloride 0.9%

Drug

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 names: NaCl 0.9%

Methylprednisolone Acetate

Drug

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

Other names: Dépomédrol

Ultrasound-guided Needling and Lavage

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: CALCECHO

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2015
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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