Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
CALCECHO
1 other identifier
interventional
136
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2015
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedStudy Start
First participant enrolled
April 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2017
CompletedOctober 17, 2018
October 1, 2018
2 years
March 20, 2015
October 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (24)
Anti-inflammatory and analgesic intake
7 days
Size of the calcific deposit
7 days
Size of the calcific deposit
3 months
Size of the calcific deposit
12 months
Number of frozen shoulder in each group
7 days
- +19 more secondary outcomes
Study Arms (2)
Experimental group (Sodium Chloride 0.9%)
EXPERIMENTALNeedling 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 COMPARATORNeedling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Interventions
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.
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
La Roche sur Yon Hospital
La Roche-sur-Yon, France
Nantes University Hospital
Nantes, 44093, France
Rennes University hospital
Rennes, France
Related Publications (2)
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.
PMID: 33719606DERIVEDDarrieutort-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.
PMID: 30975645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 31, 2015
Study Start
April 4, 2015
Primary Completion
April 2, 2017
Study Completion
November 13, 2017
Last Updated
October 17, 2018
Record last verified: 2018-10