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Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

Primary Purpose

Calcific Tendinitis

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Barbotage
Dexamethasone
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcific Tendinitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Barbotage Injection

Barbotage with Cortisone Injection

Arm Description

Subjects receiving barbotage with saline injection

Subjects receiving barbotage with cortisone injection

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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.
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.
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.
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.
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
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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2019
Last Updated
October 4, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04126278
Brief Title
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection
Official Title
Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Barbotage Injection
Arm Type
Experimental
Arm Description
Subjects receiving barbotage with saline injection
Arm Title
Barbotage with Cortisone Injection
Arm Type
Active Comparator
Arm Description
Subjects receiving barbotage with cortisone injection
Intervention Type
Drug
Intervention Name(s)
Barbotage
Intervention Description
Administered as per standard of care
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
cortisone
Intervention Description
4 mg of dexamethasone
Primary Outcome Measure Information:
Title
Clinical improvement measured by change in Visual Analog Scale (VAS)
Description
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).
Time Frame
Visit 1 Day 0
Title
Clinical improvement measured by change in Visual Analog Scale (VAS)
Description
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).
Time Frame
Visit 2 Week 6
Title
Clinical improvement measured by change in Visual Analog Scale (VAS)
Description
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).
Time Frame
Visit 3 Month 3
Title
Clinical improvement measured by change in Visual Analog Scale (VAS)
Description
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).
Time Frame
Visit 4 Month 6
Title
Clinical improvement measured by change in QuickDASH
Description
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.
Time Frame
Visit 1 Day 0
Title
Clinical improvement measured by change in QuickDASH
Description
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.
Time Frame
Visit 4 Month 6
Title
Clinical improvement measured by change in ASES Shoulder Index
Description
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.
Time Frame
Visit 1 Day 0
Title
Clinical improvement measured by change in ASES Shoulder Index
Description
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.
Time Frame
Visit 4 Month 6
Title
Clinical improvement measured by change in radiographic size of calcium deposit.
Description
Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes
Time Frame
Visit 1 Day 0
Title
Clinical improvement measured by change in radiographic size of calcium deposit.
Description
Analysis of size of the calcified deposit after aspiration and lavage will be assessed with Shoulder X-rays and correlate with the primary outcomes
Time Frame
Visit 4 Month 6.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Fried
Phone
(516) 477-0764
Email
Jordan.Fried@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehul Shah
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Fried
Phone
516-477-0764
Email
jordon.fried@nyulangone.rog
First Name & Middle Initial & Last Name & Degree
Mehul Shah

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
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.

Learn more about this trial

Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

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