Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study

19-01299

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.

2020-12-01

2022-08-12

2022-08-23

Terminated

Early phase I

4

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 * 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 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2024-01-05