Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis | NCT02986035

Studies
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

NCT02986035

Sponsor

Consorci Sanitari del Maresme

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Calcifying Shoulder Tendinitis

Interventions

ECA cream

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Dec 5, 2016

First Posted Date

Dec 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Name	Class
PRODUCTOS SANITARIOS ECA-RVB SLI	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Intervention	Experimental		Other: ECA cream

Name	Type	Description	Arm Group Labels	Other Names
ECA cream	Other		Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of shoulder calcifications	X-ray	2 months
Size of shoulder calcifications	Ultrasonography	2 months

Secondary Outcomes

Measure	Description	Time Frame
Shoulder functionality	Constant Scale	1 and 2 months
Shoulder pain	Pain VAS (Visual Analogue Scale )	1 and 2 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Consorci Sanitari del Maresme		Mataró	Barcelona	08304	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070656	Rotator Cuff Tear Arthropathy

Ancestor Terms

ID	Term
D002805	Chondrocalcinosis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided