Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

Phase 4TerminatedNCT04126278

NYU Langone Health4 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Calcific Tendinitis

Interventions

BarbotageDRUG

Administered as per standard of care

DexamethasoneDRUG

4 mg of dexamethasone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Visit 1 (Day 0)

QuickDASH Score at Visit 4

Time frame: Visit 4 (Month 6)

Data from ClinicalTrials.gov

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