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Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis (ECA)

Primary Purpose

Calcifying Shoulder Tendinitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ECA cream
Sponsored by
Consorci Sanitari del Maresme
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcifying Shoulder Tendinitis

Eligibility Criteria

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

Inclusion Criteria:

  • patients >=18 years
  • diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray
  • with disease evolution of more than 3 months and less than 12 months
  • that give their informed consent by writing

Exclusion Criteria:

  • Previous shoulder surgery patients
  • Patients with shoulder affections treated with shockwaves or corticosteroid injections.

Sites / Locations

  • Consorci Sanitari del Maresme

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Presence of shoulder calcifications
X-ray
Size of shoulder calcifications
Ultrasonography

Secondary Outcome Measures

Shoulder functionality
Constant Scale
Shoulder pain
Pain VAS (Visual Analogue Scale )

Full Information

First Posted
November 28, 2016
Last Updated
January 30, 2017
Sponsor
Consorci Sanitari del Maresme
Collaborators
PRODUCTOS SANITARIOS ECA-RVB SLI
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1. Study Identification

Unique Protocol Identification Number
NCT02986035
Brief Title
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
Acronym
ECA
Official Title
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci Sanitari del Maresme
Collaborators
PRODUCTOS SANITARIOS ECA-RVB SLI

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying shoulder tendinitis in terms of: Reduction or removal of shoulder calcifications Functional improvements Pain improvements 10 subjects will be assessed prior and 1 and 2 months post intervention onset. The intervention will consist in the application of the ECA cream in the affected shoulder twice a day during 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcifying Shoulder Tendinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
ECA cream
Primary Outcome Measure Information:
Title
Presence of shoulder calcifications
Description
X-ray
Time Frame
2 months
Title
Size of shoulder calcifications
Description
Ultrasonography
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Shoulder functionality
Description
Constant Scale
Time Frame
1 and 2 months
Title
Shoulder pain
Description
Pain VAS (Visual Analogue Scale )
Time Frame
1 and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients >=18 years diagnosed of calcifying shoulder tendinitis diagnosed by a medical specialist (rehabilitation, orthopedic surgeon or rheumatologist) by x-ray with disease evolution of more than 3 months and less than 12 months that give their informed consent by writing Exclusion Criteria: Previous shoulder surgery patients Patients with shoulder affections treated with shockwaves or corticosteroid injections.
Facility Information:
Facility Name
Consorci Sanitari del Maresme
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

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