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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-04

Study Completion Date

2017-11-13

Brief Summary

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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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Detailed Description

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Conditions

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Calcifying Tendinitis of Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group (Sodium 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.

Group Type EXPERIMENTAL

Sodium Chloride 0.9%

Intervention Type 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.

Ultrasound-guided Needling and Lavage

Intervention Type PROCEDURE

Control group (Methylprednisolone Acetate)

Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae

Group Type ACTIVE_COMPARATOR

Methylprednisolone acetate

Intervention Type 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

Intervention Type PROCEDURE

Interventions

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Sodium 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.

Intervention Type DRUG

Methylprednisolone acetate

Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae

Intervention Type DRUG

Ultrasound-guided Needling and Lavage

Intervention Type PROCEDURE

Other Intervention Names

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NaCl 0.9% Dépomédrol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No