NCT02986035

Brief Summary

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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2016

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

Same day

First QC Date

November 28, 2016

Last Update Submit

January 30, 2017

Conditions

Calcifying Shoulder Tendinitis

Outcome Measures

Primary Outcomes (2)

  • Presence of shoulder calcifications

    X-ray

    2 months

  • Size of shoulder calcifications

    Ultrasonography

    2 months

Secondary Outcomes (2)

  • Shoulder functionality

    1 and 2 months

  • Shoulder pain

    1 and 2 months

Study Arms (1)

Intervention

EXPERIMENTAL
Other: ECA cream

Interventions

ECA creamOTHER
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

ChondrocalcinosisArthritisJoint DiseasesMusculoskeletal DiseasesCrystal Arthropathies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 28, 2016

First Posted

December 7, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)