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

October 16, 2018 updated by: Nantes University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche sur Yon, France
        • La Roche Sur Yon Hospital
      • Nantes, France, 44093
        • Nantes University Hospital
      • Rennes, France
        • Rennes university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • NaCl 0.9%
Procedure: Ultrasound-guided Needling and Lavage
Active Comparator: 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
Procedure: Ultrasound-guided Needling and Lavage
Drug: Methylprednisolone acetate
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Other Names:
  • Dépomédrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum pain (VAS scale)
Time Frame: 7 days
Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Anti-inflammatory and analgesic intake
Time Frame: 7 days
7 days
Size of the calcific deposit
Time Frame: 7 days
7 days
Size of the calcific deposit
Time Frame: 3 months
3 months
Size of the calcific deposit
Time Frame: 12 months
12 months
Number of frozen shoulder in each group
Time Frame: 7 days
7 days
Number of frozen shoulder in each group
Time Frame: 6 weeks
6 weeks
Number of frozen shoulder in each group
Time Frame: 3 months
3 months
Number of frozen shoulder in each group
Time Frame: 6 months
6 months
Number of frozen shoulder in each group
Time Frame: 12 months
12 months
VAS pain during daily activity
Time Frame: 7 days
7 days
VAS pain during daily activity
Time Frame: 6 weeks
6 weeks
VAS pain during daily activity
Time Frame: 3 months
3 months
VAS pain during daily activity
Time Frame: 6 months
6 months
VAS pain during daily activity
Time Frame: 12 months
12 months
VAS pain at rest
Time Frame: 7 days
7 days
VAS pain at rest
Time Frame: 6 weeks
6 weeks
VAS pain at rest
Time Frame: 3 months
3 months
VAS pain at rest
Time Frame: 6 months
6 months
VAS pain at rest
Time Frame: 12 months
12 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 7 days
7 days
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 6 weeks
6 weeks
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 3 months
3 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 6 months
6 months
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2015

Primary Completion (Actual)

April 2, 2017

Study Completion (Actual)

November 13, 2017

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC15_0019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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