Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection

Calcific Tendinitis Clinical Trial

Official title:

Calcific Tendonitis Treatment: Barbotage vs. Barbotage With Cortisone Injection: A Randomized Controlled Double-Blind Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04126278
• Other study ID #: 19-01299
• Status: Terminated
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: August 23, 2022

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 23, 2022
• Est. primary completion date: August 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcific Tendinitis
• Tendinopathy

Intervention

Drug:
• Barbotage
Administered as per standard of care
• Dexamethasone
4 mg of dexamethasone

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Radiographic Size of Calcium Deposit at Visit 1	Size of calcium deposit will be assessed with Shoulder X-rays.	Visit 1 (Day 0)
Primary	Radiographic Size of Calcium Deposit at Visit 4	Size of calcium deposit will be assessed with Shoulder X-rays.	Visit 4 (Month 6)