Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

NCT ID: NCT04126278

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-08-23

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.

Conditions

Calcific Tendinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Barbotage Injection

Subjects receiving barbotage with saline injection

Group Type: EXPERIMENTAL

Barbotage

Intervention Type: DRUG

Administered as per standard of care

Barbotage with Cortisone Injection

Subjects receiving barbotage with cortisone injection

Group Type: ACTIVE_COMPARATOR

Barbotage

Intervention Type: DRUG

Administered as per standard of care

Dexamethasone

Intervention Type: DRUG

4 mg of dexamethasone

Interventions

Barbotage

Administered as per standard of care

Intervention Type: DRUG

Dexamethasone

4 mg of dexamethasone

Intervention Type: DRUG

Other Intervention Names

cortisone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehul Shah

Role: PRINCIPAL_INVESTIGATOR

NYU Langone

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-01299

Identifier Type: -

Identifier Source: org_study_id