Clinical trial NCT02403856: Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Calcifying Tendinitis of Shoulder
Keywords: calcifying tendinitis
Needle lavage
Shoulder
Corticosteroid injection
Ultrasound-guided
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maximum pain (VAS scale)
timeFrame: 7 days
Secondary outcomes:
measure: Anti-inflammatory and analgesic intake
timeFrame: 7 days
measure: Size of the calcific deposit
timeFrame: 7 days
measure: Size of the calcific deposit
timeFrame: 3 months
measure: Size of the calcific deposit
timeFrame: 12 months
measure: Number of frozen shoulder in each group
timeFrame: 7 days
measure: Number of frozen shoulder in each group
timeFrame: 6 weeks
measure: Number of frozen shoulder in each group
timeFrame: 3 months
measure: Number of frozen shoulder in each group
timeFrame: 6 months
measure: Number of frozen shoulder in each group
timeFrame: 12 months
measure: VAS pain during daily activity
timeFrame: 7 days
measure: VAS pain during daily activity
timeFrame: 6 weeks
measure: VAS pain during daily activity
timeFrame: 3 months
measure: VAS pain during daily activity
timeFrame: 6 months
measure: VAS pain during daily activity
timeFrame: 12 months
measure: VAS pain at rest
timeFrame: 7 days
measure: VAS pain at rest
timeFrame: 6 weeks
measure: VAS pain at rest
timeFrame: 3 months
measure: VAS pain at rest
timeFrame: 6 months
measure: VAS pain at rest
timeFrame: 12 months
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 7 days
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 6 weeks
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 3 months
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 6 months
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: 12 months
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University hospital
Study officials:
References:
citation: 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.
citation: 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.