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OpenTrials
Completed

NCT Number: NCT02986035

Effectiveness of ECA Cream on Calcifying Shoulder Tendinitis

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.

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Key information

Conditions

Calcifying Shoulder Tendinitis Arthritis Chondrocalcinosis Crystal Arthropathies Joint Diseases Musculoskeletal Diseases Rotator Cuff Tear Arthropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari del Maresme

Mataró, Barcelona, 08304, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ECA cream

Other

Primary outcomes

  1. Presence of shoulder calcifications

    Time frame: 2 months

    X-ray

  2. Size of shoulder calcifications

    Time frame: 2 months

    Ultrasonography

Secondary outcomes

  1. Shoulder functionality

    Time frame: 1 and 2 months

    Constant Scale

  2. Shoulder pain

    Time frame: 1 and 2 months

    Pain VAS (Visual Analogue Scale )

Sponsors and collaborators

Lead sponsor

Consorci Sanitari del Maresme

Other

Collaborators

  • PRODUCTOS SANITARIOS ECA-RVB SLI

Registry information

Acronym: ECA

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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