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Barbotage for Calcific Tendinitis
Study Summary
This trial is testing whether a cortisone injection improves the effectiveness of barbotage, a therapy involving numbing and then breaking up scar tissue with a needle.
- Calcific Tendinitis
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Barbotage with Cortisone Injection
- Group 2: Barbotage Injection
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
- 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.
Frequently Asked Questions
What other research endeavors have focused on Barbotage?
"Currently, 599 trials related to Barbotage are being conducted. Of those active studies, 150 have reached the third phase of testing. These researches are mainly centered in Duarte, California but there is a total of 21987 clinical trial sites for this treatment throughout the world."
How many subjects is the research group recruiting for this trial?
"Affirmative. The info on clinicaltrials.gov demonstrates that this investigation is currently recruiting volunteers, having been first listed on December 1st 2020 and most recently tweaked on October 4th 2022. 150 patients need to be enlisted across a single research centre."
In what capacity is Barbotage most commonly employed?
"Barbotage is a common treatment for ophthalmic and sympathetic issues, but it can also be utilized to manage macular edema in the event of branch retinal vein occlusion."
Is there an opportunity to partake in this clinical experiment?
"To be eligible for the trial, participants must have tendinitis and fall between the ages of 18 to 90. The medical study has capacity for a total of 150 patients."
Has the FDA approved Barbotage as a valid therapeutic approach?
"As this treatment is approved and currently in Phase 4 trials, the safety rating for Barbotage has been set at 3."
Has registration opened for this clinical investigation yet?
"Per the information on clinicaltrials.gov, this trial is still open for recruitment and has been since December 1st 2020 with its most recent edit occuring October 4th 2022."
Does the research team accept participants aged 35 and over?
"This trial's eligibility requirements demand that participants be aged between 18 to 90 years old. Additionally, there are 83 trials for minors and 584 studies targeting seniors."
Who else is applying?
What state do they live in?
How old are they?
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