Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Calcific Tendinitis

Intervention / Treatment
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* Drug: Barbotage
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Barbotage Injection<br>Subjects receiving barbotage with saline injection | Drug: Barbotage<br>* Administered as per standard of care<br>|
| Active Comparator: Barbotage with Cortisone Injection<br>Subjects receiving barbotage with cortisone injection | Drug: Barbotage<br>* Administered as per standard of care<br>Drug: Dexamethasone<br>* 4 mg of dexamethasone<br>* Other names: cortisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement measured by change in Visual Analog Scale (VAS) | 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 | 
| Clinical improvement measured by change in Visual Analog Scale (VAS) | 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 | 
| Clinical improvement measured by change in Visual Analog Scale (VAS) | 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 | 
| Clinical improvement measured by change in Visual Analog Scale (VAS) | 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 | 
| Clinical improvement measured by change in QuickDASH | 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. | Visit 1 Day 0 | 
| Clinical improvement measured by change in QuickDASH | 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. | Visit 4 Month 6 | 
| Clinical improvement measured by change in ASES Shoulder Index | 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. | Visit 1 Day 0 | 
| Clinical improvement measured by change in ASES Shoulder Index | 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. | Visit 4 Month 6 | 
| Clinical improvement measured by change in radiographic size of calcium deposit. | Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes | Visit 1 Day 0 | 
| Clinical improvement measured by change in radiographic size of calcium deposit. | Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes | Visit 4 Month 6. |