Calcific Tendinitis Clinical Trial
Official title:
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study
Verified date | December 2023 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 23, 2022 |
Est. primary completion date | August 12, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU Langone Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual Analog Scale (VAS) Score at Visit 1 | Pain will be assessed by the Visual Analog Scale which describes pain in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | Visit 1 (Day 0) | |
Primary | VAS Score at Visit 2 | Pain will be assessed by the Visual Analog Scale which describes pain in in terms of no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | Visit 2 (Week 6) | |
Primary | VAS Score at Visit 3 | Pain will be assessed by the Visual Analog Scale which describes pain in terms or sdlk no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | Visit 3 (Month 3) | |
Primary | VAS Score at Visit 4 | Pain will be assessed by the Visual Analog Scale which describes pain in no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | Visit 4 (Month 6) | |
Primary | QuickDASH Score at Visit 1 | Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities. | Visit 1 (Day 0) | |
Primary | QuickDASH Score at Visit 4 | Individual's ability to complete tasks, absorb forces, and severity of symptoms are measured by a 11-item QuickDash questionnaire using a 5 point Likert scale. The raw score is the sum of responses and is rescaled into a total score ranging from 0-100; lower scores indicate greater abilities. | Visit 4 (Month 6) | |
Primary | American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1 | 24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition. | Visit 1 (Day 0) | |
Primary | ASES Index Score at Visit 4 | 24-item assessment of pain and daily living related to shoulder conditions. Items are rated on various Likert scales. The raw score is the sum of responses and is converted to a total score. Total scores range from 0 to 100; higher scores indicate a better shoulder condition. | Visit 4 (Month 6) | |
Primary | Radiographic Size of Calcium Deposit at Visit 1 | Size of calcium deposit will be assessed with Shoulder X-rays. | Visit 1 (Day 0) | |
Primary | Radiographic Size of Calcium Deposit at Visit 4 | Size of calcium deposit will be assessed with Shoulder X-rays. | Visit 4 (Month 6) |
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