Calcifying Shoulder TendinitisECANCT02986035
Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
A study testing ECA cream in people with Calcifying Shoulder Tendinitis, run by Consorci Sanitari del Maresme at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcifying Shoulder Tendinitis
- What is being tested?
- ECA cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous shoulder surgery patients
- Patients with shoulder affections treated with shockwaves or corticosteroid injections.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Calcifying Shoulder Tendinitis
- Being tested
- ECA cream
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECA creamOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Other: ECA cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of shoulder calcifications
X-ray
Measured: 2 months
Size of shoulder calcifications
Ultrasonography
Measured: 2 months
Secondary outcomes (2)
Shoulder functionality
Constant Scale
Measured: 1 and 2 months
Shoulder pain
Pain VAS (Visual Analogue Scale )
Measured: 1 and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcifying Shoulder TendinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari del Maresme
- Sponsor type
- University, hospital or other
- Collaborators
- PRODUCTOS SANITARIOS ECA-RVB SLI
- Responsible party
- Principal investigator, Lluís Guirao, Consorci Sanitari del Maresme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986035
- Sponsor's protocol ID
- 46/16
- Acronym
- ECA
- Status last verified
- Jan 2017
- First submitted
- 28 Nov 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis
- ClinicalTrials.gov ID
- NCT02986035
- Acronym / sponsor ID
- ECA / 46/16
- Conditions
- Calcifying Shoulder Tendinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Consorci Sanitari del MaresmeUniversity, hospital or other
- Collaborators
- PRODUCTOS SANITARIOS ECA-RVB SLI
- Study start
- Oct 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ECA cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Previous shoulder surgery patients
- Patients with shoulder affections treated with shockwaves or corticosteroid injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECA cream | Other | Intervention |
Primary outcome
Presence of shoulder calcifications
Time frame: 2 months
X-ray
Size of shoulder calcifications
Time frame: 2 months
Ultrasonography
2 secondary outcomes
Shoulder functionality
Time frame: 1 and 2 months
Shoulder pain
Time frame: 1 and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Individual participant dataSharing planned: No
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Not yet recruiting
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the Shoulder
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RecruitingObservational study
A Novel Classification in Calcific Tendinitis of the Shoulder: Evaluating MRI Localization and Related Treatment Strategies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECA cream in people with Calcifying Shoulder Tendinitis, run by Consorci Sanitari del Maresme at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of shoulder calcifications (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.