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Enrollment difficulty.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Barbotage Injection | Experimental | Subjects receiving barbotage with saline injection |
|
| Barbotage with Cortisone Injection | Active Comparator | Subjects receiving barbotage with cortisone injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbotage | Drug | Administered as per standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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. |
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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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehul Shah | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Upon reasonable request. Requests should be directed to Mehul.Shah@nyulangone.org. To gain access, data requester will need to sign a data access agreement.
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This study was terminated early; no participants were enrolled in the Barbotage Injection arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Barbotage Injection | Subjects receiving barbotage with saline injection Barbotage: Administered as per standard of care |
| FG001 | Barbotage With Cortisone Injection | Subjects receiving barbotage with cortisone injection Barbotage: Administered as per standard of care Dexamethasone: 4 mg of dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No patients enrolled in the Barbotage Injection arm (see participant flow).
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| ID | Title | Description |
|---|---|---|
| BG000 | Barbotage Injection | Subjects receiving barbotage with saline injection Barbotage: Administered as per standard of care |
| BG001 | Barbotage With Cortisone Injection | Subjects receiving barbotage with cortisone injection Barbotage: Administered as per standard of care Dexamethasone: 4 mg of dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | Visit 1 (Day 0) |
|
6 months
The total number at risk in the Barbotage Injection arm for Serious Adverse Events, All-Cause Mortality, and Other Adverse events is zero because no participants were enrolled into this arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Barbotage Injection | Subjects receiving barbotage with saline injection Barbotage: Administered as per standard of care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehul Shah | NYU Langone Health | 616-501-7223 | Mehul.Shah@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2019 | Sep 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D003348 | Cortisone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug | 4 mg of dexamethasone |
|
|
| Visit 4 (Month 6) |
| 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) |
| 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) |
| Radiographic Size of Calcium Deposit at Visit 1 | Size of calcium deposit will be assessed with Shoulder X-rays. | Visit 1 (Day 0) |
| Radiographic Size of Calcium Deposit at Visit 4 | Size of calcium deposit will be assessed with Shoulder X-rays. | Visit 4 (Month 6) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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). | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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). | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | 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. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | score on a scale | Visit 4 (Month 6) |
|
|
|
| Primary | Radiographic Size of Calcium Deposit at Visit 1 | Size of calcium deposit will be assessed with Shoulder X-rays. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | centimeters (cm) | Visit 1 (Day 0) |
|
|
|
| Primary | Radiographic Size of Calcium Deposit at Visit 4 | Size of calcium deposit will be assessed with Shoulder X-rays. | No patients enrolled in the Barbotage Injection arm (see participant flow). | Posted | Mean | Standard Deviation | centimeters (cm) | Visit 4 (Month 6) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Barbotage With Cortisone Injection | Subjects receiving barbotage with cortisone injection Barbotage: Administered as per standard of care Dexamethasone: 4 mg of dexamethasone | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011283 | Pregnenes |
| D015065 | 17-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |