Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

NCT04126278 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 19-01299
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcific Tendinitis

Outcome Measures

Primary Outcomes (10)

• 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)

Study Arms (2)

Barbotage Injection

EXPERIMENTAL

Subjects receiving barbotage with saline injection

Drug: Barbotage

Barbotage with Cortisone Injection

ACTIVE COMPARATOR

Subjects receiving barbotage with cortisone injection

Drug: Barbotage; Drug: Dexamethasone

Interventions

Barbotage DRUG

Administered as per standard of care

Barbotage Injection; Barbotage with Cortisone Injection

Dexamethasone DRUG

4 mg of dexamethasone

Also known as: cortisone

Barbotage with Cortisone Injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Younger than 18 years of age or older than 90
• Any patient considered a vulnerable subject

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Dexamethasone; Cortisone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pregnenes; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Mehul Shah
• Organization: NYU Langone Health

Mehul.Shah@nyulangone.org

616-501-7223

Study Officials

• Mehul Shah

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: December 1, 2020
• Primary Completion: August 12, 2022
• Study Completion: August 23, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)