Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

NYU Langone Health

Status and phase

Terminated

Phase 4

Conditions

Calcific Tendinitis

Treatments

Drug: Barbotage

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT04126278

19-01299

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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