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Barbotage for Calcific Tendinitis
Phase 4
Waitlist Available
Led By Mehul Shah
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 4 (month 6)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing barbotage therapy, which involves injecting and washing the shoulder joint with saline, on patients with calcific tendonitis. The goal is to see if this method reduces pain and improves shoulder function. Barbotage therapy, also known as needling and lavage, has been frequently used in the treatment of calcific tendinitis of the rotator cuff.
Eligible Conditions
- Calcific Tendinitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 4 (month 6)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 4 (month 6)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
ASES Index Score at Visit 4
American Shoulder and Elbow Surgeons (ASES) Index Score at Visit 1
QuickDASH Score at Visit 1
+7 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Barbotage InjectionExperimental Treatment1 Intervention
Subjects receiving barbotage with saline injection
Group II: Barbotage with Cortisone InjectionActive Control2 Interventions
Subjects receiving barbotage with cortisone injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Barbotage
2015
N/A
~220
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,811 Total Patients Enrolled
Mehul ShahPrincipal InvestigatorNYU Langone
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have osteoarthritis in your shoulder joint.You have certain shoulder or joint problems like arthritis, inflammation, or nerve issues.You have had surgery or barbotage on your shoulder before.Patients who are considered vulnerable due to their age, health condition, or other factors.You have received a corticosteroid injection or ESWT treatment in your shoulder within the last 3 months before joining the study.You have been diagnosed with calcific tendonitis and other shoulder problems have been ruled out.You are younger than 18 years of age.You plan to have a medical procedure called barbotage with cortisone as part of your normal treatment.You have failed 1st line therapy (physical therapy and cortisone injection) and you are aged 18 or older.You have experienced pain in your shoulder for 3 or more months.You had an allergic or hypersensitivity reaction to the study medication in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Barbotage with Cortisone Injection
- Group 2: Barbotage Injection
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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