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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02403856
Acronym
CALCECHO
Enrollment
136
Registered
2015-03-31
Start date
2015-04-04
Completion date
2017-11-13
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcifying Tendinitis of Shoulder

Keywords

calcifying tendinitis, Needle lavage, Shoulder, Corticosteroid injection, Ultrasound-guided

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.

Interventions

DRUGSodium Chloride 0.9%

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

PROCEDUREUltrasound-guided Needling and Lavage

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum pain (VAS scale)7 daysMaximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.

Secondary

MeasureTime frame
Size of the calcific deposit7 days
Number of frozen shoulder in each group7 days
Anti-inflammatory and analgesic intake7 days
VAS pain at rest7 days
The Disabilities of the Arm, Shoulder and Hand (DASH) Score7 days
VAS pain during daily activity7 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026