Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

  • STATUS
    Recruiting
  • End date
    Nov 19, 2022
  • participants needed
    150
  • sponsor
    NYU Langone Health
Updated on 19 November 2021

Summary

The purpose of this study is to determine the efficacy of barbotage therapy by comparing the clinical and sonographic changes in patients that solely receive barbotage to patients receiving the standard of care, barbotage with cortisone injection.

Description

Calcific tendonitis is a condition caused by calcium deposits building up in a person's muscles or tendons. If calcium builds up in an area, a person may feel pain and discomfort there. The purpose of this study is to determine the efficacy of barbotage therapy (injecting and washing the shoulder joint with saline) by comparing the amount of pain, shoulder function, and X-Rays in patients with calcific tendonitis that receive the standard of care, barbotage with cortisone injection, against barbotage with saline injection. Receiving barbotage without cortisone is therefore considered experimental.

Details
Condition Calcific Tendinitis
Treatment Dexamethasone, Barbotage
Clinical Study IdentifierNCT04126278
SponsorNYU Langone Health
Last Modified on19 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be at least 18 years of age and younger than 90 years of age
Diagnosed with calcific tendonitis and ruled out other shoulder-related pathologies
Failed 1st line therapy (physical therapy and cortisone injection)
Intention to receive barbotage with cortisone as standard of care
or more months of shoulder pain
Finding of one or more calcifications 5 mm in size on either sonogram or radiograph, located on the supraspinatus tendon
Positive Hawkin's test or Neer's sign for impingement

Exclusion Criteria

Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
Osteoarthritis of the glenohumeral joint of the affected shoulder
Previous surgery or barbotage to the affected shoulder
History of prior allergic/hypersensitivity reactions related to the study medication
Shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
Sub-acromial injection with a corticosteroid or treatment by ESWT during the last 3 months before inclusion
Younger than 18 years of age or older than 90
Any patient considered a vulnerable subject
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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