Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Study Details
Study Description
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 standard of care, barbotage with cortisone injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Barbotage Injection Subjects receiving barbotage with saline injection |
Drug: Barbotage
Administered as per standard of care
|
| Active Comparator: Barbotage with Cortisone Injection Subjects receiving barbotage with cortisone injection |
Drug: Barbotage
Administered as per standard of care
Drug: Dexamethasone
4 mg of dexamethasone
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical improvement measured by change in Visual Analog Scale (VAS) [Visit 1 Day 0]
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).
- Clinical improvement measured by change in Visual Analog Scale (VAS) [Visit 2 Week 6]
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).
- Clinical improvement measured by change in Visual Analog Scale (VAS) [Visit 3 Month 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).
- Clinical improvement measured by change in Visual Analog Scale (VAS) [Visit 4 Month 6]
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).
- Clinical improvement measured by change in QuickDASH [Visit 1 Day 0]
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.
- Clinical improvement measured by change in QuickDASH [Visit 4 Month 6]
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.
- Clinical improvement measured by change in ASES Shoulder Index [Visit 1 Day 0]
Subject's joint pain, instability, and activities of daily living will be assessed by the ASES which includes 7 items on pain and 17 items on daily living.
- Clinical improvement measured by change in ASES Shoulder Index [Visit 4 Month 6]
Subject's joint pain, instability, and activities of daily living will be assessed by the ASES which includes 7 items on pain and 17 items on daily living.
- Clinical improvement measured by change in radiographic size of calcium deposit. [Visit 1 Day 0]
Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes
- Clinical improvement measured by change in radiographic size of calcium deposit. [Visit 4 Month 6.]
Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Mehul Shah, NYU Langone
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-01299