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Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis (ECA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Consorci Sanitari del Maresme
Sponsor:
Collaborator:
PRODUCTOS SANITARIOS ECA-RVB SLI
Information provided by (Responsible Party):
Lluís Guirao, Consorci Sanitari del Maresme
ClinicalTrials.gov Identifier:
NCT02986035
First received: November 28, 2016
Last updated: December 5, 2016
Last verified: October 2016
  Purpose

This pilot trail aims to assess the effectiveness of ECA cream in the treatment of calcifying shoulder tendinitis in terms of:

  1. Reduction or removal of shoulder calcifications
  2. Functional improvements
  3. 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.

Condition Intervention
Calcifying Shoulder Tendinitis
Other: ECA cream

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

Further study details as provided by Consorci Sanitari del Maresme:

Primary Outcome Measures:
  • Presence of shoulder calcifications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    X-ray

  • Size of shoulder calcifications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    Ultrasonography


Secondary Outcome Measures:
  • Shoulder functionality [ Time Frame: 1 and 2 months ] [ Designated as safety issue: Yes ]
    Constant Scale

  • Shoulder pain [ Time Frame: 1 and 2 months ] [ Designated as safety issue: Yes ]
    Pain VAS (Visual Analogue Scale )


Estimated Enrollment: 10
Study Start Date: October 2016
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Other: ECA cream

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02986035

Contacts
Contact: Lluís Guirao, PhD 0034937417728 lguirao@csdm.cat

Locations
Spain
Consorci Sanitari del Maresme Recruiting
Mataró, Barcelona, Spain, 08304
Contact: Mateu Serra-Prat, PhD    0034937417730    mserra@csdm.cat   
Principal Investigator: Mateu Serra-Prat, PhD         
Sponsors and Collaborators
Consorci Sanitari del Maresme
PRODUCTOS SANITARIOS ECA-RVB SLI
  More Information

Responsible Party: Lluís Guirao, PhD, Consorci Sanitari del Maresme
ClinicalTrials.gov Identifier: NCT02986035     History of Changes
Other Study ID Numbers: 46/16 
Study First Received: November 28, 2016
Last Updated: December 5, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on December 07, 2016