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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (Sodium Chloride 0.9%) | Experimental | 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. |
|
| Control group (Methylprednisolone Acetate) | Active Comparator | Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-inflammatory and analgesic intake | 7 days | |
| Size of the calcific deposit | 7 days | |
| Size of the calcific deposit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Roche sur Yon Hospital | La Roche-sur-Yon | France | ||||
| Nantes University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33719606 | Derived | Dumoulin N, Cormier G, Varin S, Coiffier G, Albert JD, Le Goff B, Darrieutort-Laffite C. Factors Associated With Clinical Improvement and the Disappearance of Calcifications After Ultrasound-Guided Percutaneous Lavage of Rotator Cuff Calcific Tendinopathy: A Post Hoc Analysis of a Randomized Controlled Trial. Am J Sports Med. 2021 Mar;49(4):883-891. doi: 10.1177/0363546521992359. | |
| 30975645 |
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|
| Methylprednisolone acetate | Drug | Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae |
|
|
| Ultrasound-guided Needling and Lavage | Procedure |
|
| 3 months |
| Size of the calcific deposit | 12 months |
| Number of frozen shoulder in each group | 7 days |
| Number of frozen shoulder in each group | 6 weeks |
| Number of frozen shoulder in each group | 3 months |
| Number of frozen shoulder in each group | 6 months |
| Number of frozen shoulder in each group | 12 months |
| VAS pain during daily activity | 7 days |
| VAS pain during daily activity | 6 weeks |
| VAS pain during daily activity | 3 months |
| VAS pain during daily activity | 6 months |
| VAS pain during daily activity | 12 months |
| VAS pain at rest | 7 days |
| VAS pain at rest | 6 weeks |
| VAS pain at rest | 3 months |
| VAS pain at rest | 6 months |
| VAS pain at rest | 12 months |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 7 days |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 6 weeks |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 3 months |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 6 months |
| The Disabilities of the Arm, Shoulder and Hand (DASH) Score | 12 months |
| Nantes |
| 44093 |
| France |
| Rennes University hospital | Rennes | France |
| Derived |
| Darrieutort-Laffite C, Varin S, Coiffier G, Albert JD, Planche L, Maugars Y, Cormier G, Le Goff B. Are corticosteroid injections needed after needling and lavage of calcific tendinitis? Randomised, double-blind, non-inferiority trial. Ann Rheum Dis. 2019 Jun;78(6):837-843. doi: 10.1136/annrheumdis-2018-214971. Epub 2019 Apr 11. |
| ID | Term |
|---|---|
| D000070656 | Rotator Cuff Tear Arthropathy |
| ID | Term |
|---|---|
| D002805 | Chondrocalcinosis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077555 | Methylprednisolone Acetate |
| D007507 | Therapeutic Irrigation |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |
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