Calcifying Tendinitis of Shoulder Clinical Trial
— CALCECHOOfficial 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
| Verified date | October 2018 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | November 13, 2017 |
| Est. primary completion date | April 2, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | La Roche sur Yon Hospital | La Roche sur Yon | |
| France | Nantes University Hospital | Nantes | |
| France | Rennes University hospital | Rennes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum pain (VAS scale) | Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling. | 7 days | |
| Secondary | Anti-inflammatory and analgesic intake | 7 days | ||
| Secondary | Size of the calcific deposit | 7 days | ||
| Secondary | Size of the calcific deposit | 3 months | ||
| Secondary | Size of the calcific deposit | 12 months | ||
| Secondary | Number of frozen shoulder in each group | 7 days | ||
| Secondary | Number of frozen shoulder in each group | 6 weeks | ||
| Secondary | Number of frozen shoulder in each group | 3 months | ||
| Secondary | Number of frozen shoulder in each group | 6 months | ||
| Secondary | Number of frozen shoulder in each group | 12 months | ||
| Secondary | VAS pain during daily activity | 7 days | ||
| Secondary | VAS pain during daily activity | 6 weeks | ||
| Secondary | VAS pain during daily activity | 3 months | ||
| Secondary | VAS pain during daily activity | 6 months | ||
| Secondary | VAS pain during daily activity | 12 months | ||
| Secondary | VAS pain at rest | 7 days | ||
| Secondary | VAS pain at rest | 6 weeks | ||
| Secondary | VAS pain at rest | 3 months | ||
| Secondary | VAS pain at rest | 6 months | ||
| Secondary | VAS pain at rest | 12 months | ||
| Secondary | The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 7 days | ||
| Secondary | The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 6 weeks | ||
| Secondary | The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 3 months | ||
| Secondary | The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 6 months | ||
| Secondary | The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 12 months |