Status:
TERMINATED
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Lead Sponsor:
NYU Langone Health
Conditions:
Calcific Tendinitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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 standa...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 3 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04126278
Start Date
December 1 2020
End Date
August 23 2022
Last Update
January 5 2024
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016