Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

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

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.

Study Overview

• Status: Terminated
• Conditions: Calcific Tendinitis
• Intervention / Treatment: Drug: Barbotage; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: cortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Mehul Shah, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): August 12, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Cortisone
• Other Study ID Numbers: 19-01299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• 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