Clinical trial NCT04126278: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Calcific Tendinitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Scale (VAS) Score at Visit 1
timeFrame: Visit 1 (Day 0)
measure: VAS Score at Visit 2
timeFrame: Visit 2 (Week 6)
measure: VAS Score at Visit 3
timeFrame: Visit 3 (Month 3)
measure: VAS Score at Visit 4
timeFrame: Visit 4 (Month 6)
measure: QuickDASH Score at Visit 1
timeFrame: Visit 1 (Day 0)
measure: QuickDASH Score at Visit 4
timeFrame: Visit 4 (Month 6)
measure: American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
timeFrame: Visit 1 (Day 0)
measure: ASES Index Score at Visit 4
timeFrame: Visit 4 (Month 6)
measure: Radiographic Size of Calcium Deposit at Visit 1
timeFrame: Visit 1 (Day 0)
measure: Radiographic Size of Calcium Deposit at Visit 4
timeFrame: Visit 4 (Month 6)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Mehul Shah
role: PRINCIPAL_INVESTIGATOR
References: