Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

Calcifying Shoulder Tendinitis Clinical Trial

— ECA  

Official title:

Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986035
• Other study ID #: 46/16
• Status: Completed
• Phase: N/A
• First received: November 28, 2016
• Last updated: January 30, 2017
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Consorci Sanitari del Maresme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calcifying Shoulder Tendinitis
• Tendinopathy

Intervention

Other:
• ECA cream

Locations

Country	Name	City	State
Spain	Consorci Sanitari del Maresme	Mataró	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari del Maresme	PRODUCTOS SANITARIOS ECA-RVB SLI

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of shoulder calcifications	X-ray	2 months
Primary	Size of shoulder calcifications	Ultrasonography	2 months
Secondary	Shoulder functionality	Constant Scale	1 and 2 months
Secondary	Shoulder pain	Pain VAS (Visual Analogue Scale )	1 and 2 months