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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 (CALCECHO)

Primary Purpose

Calcifying Tendinitis of Shoulder

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Sodium Chloride 0.9%
Methylprednisolone acetate
Ultrasound-guided Needling and Lavage
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcifying Tendinitis of Shoulder focused on measuring calcifying tendinitis, Needle lavage, Shoulder, Corticosteroid injection, Ultrasound-guided

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • La Roche sur Yon Hospital
  • Nantes University Hospital
  • Rennes University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group (Sodium Chloride 0.9%)

Control group (Methylprednisolone Acetate)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Anti-inflammatory and analgesic intake
Size of the calcific deposit
Size of the calcific deposit
Size of the calcific deposit
Number of frozen shoulder in each group
Number of frozen shoulder in each group
Number of frozen shoulder in each group
Number of frozen shoulder in each group
Number of frozen shoulder in each group
VAS pain during daily activity
VAS pain during daily activity
VAS pain during daily activity
VAS pain during daily activity
VAS pain during daily activity
VAS pain at rest
VAS pain at rest
VAS pain at rest
VAS pain at rest
VAS pain at rest
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
The Disabilities of the Arm, Shoulder and Hand (DASH) Score

Full Information

First Posted
March 20, 2015
Last Updated
October 16, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02403856
Brief Title
Efficacy and Tolerance of Ultrasound-guided Needling and Lavage of Calcific Tendinitis of the Rotator Cuff Performed With or Without Subacromial Corticosteroid Injection
Acronym
CALCECHO
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2015 (Actual)
Primary Completion Date
April 2, 2017 (Actual)
Study Completion Date
November 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcifying Tendinitis of Shoulder
Keywords
calcifying tendinitis, Needle lavage, Shoulder, Corticosteroid injection, Ultrasound-guided

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (Sodium Chloride 0.9%)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (Methylprednisolone Acetate)
Arm Type
Active Comparator
Arm Description
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9%
Other Intervention Name(s)
NaCl 0.9%
Intervention Description
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
Intervention Name(s)
Methylprednisolone acetate
Other Intervention Name(s)
Dépomédrol
Intervention Description
Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Needling and Lavage
Primary Outcome Measure Information:
Title
Maximum pain (VAS scale)
Description
Maximum pain on a VAS scale (0-10) reported by the patient in the seven days following the needling.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Anti-inflammatory and analgesic intake
Time Frame
7 days
Title
Size of the calcific deposit
Time Frame
7 days
Title
Size of the calcific deposit
Time Frame
3 months
Title
Size of the calcific deposit
Time Frame
12 months
Title
Number of frozen shoulder in each group
Time Frame
7 days
Title
Number of frozen shoulder in each group
Time Frame
6 weeks
Title
Number of frozen shoulder in each group
Time Frame
3 months
Title
Number of frozen shoulder in each group
Time Frame
6 months
Title
Number of frozen shoulder in each group
Time Frame
12 months
Title
VAS pain during daily activity
Time Frame
7 days
Title
VAS pain during daily activity
Time Frame
6 weeks
Title
VAS pain during daily activity
Time Frame
3 months
Title
VAS pain during daily activity
Time Frame
6 months
Title
VAS pain during daily activity
Time Frame
12 months
Title
VAS pain at rest
Time Frame
7 days
Title
VAS pain at rest
Time Frame
6 weeks
Title
VAS pain at rest
Time Frame
3 months
Title
VAS pain at rest
Time Frame
6 months
Title
VAS pain at rest
Time Frame
12 months
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
7 days
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
6 weeks
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
3 months
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
6 months
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
La Roche sur Yon Hospital
City
La Roche sur Yon
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Rennes University hospital
City
Rennes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33719606
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.
Results Reference
derived
PubMed Identifier
30975645
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.
Results Reference
derived

Learn more about this trial

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

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