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Corticosteroid

PRP vs Corticosteroids vs Lidocaine for Joint Pain

Phase 4
Recruiting
Led By Daniel Rhon, DSc
Research Sponsored by Brooke Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the 1 year period after enrollment
Awards & highlights

Study Summary

This trial will compare three different injections to treat ACJ Dysfunction. One group will get a corticosteroid, one group will get Platelet Rich Plasma, and one group will get Lidocaine. Doctors will follow patients for one year to see how well the treatments work.

Who is the study for?
This trial is for TRICARE beneficiaries aged 18-65 with AC joint pain, who can consent in English and have tenderness or pain during specific tests. Excluded are those with recent invasive shoulder treatments, leaving the military soon, systemic diseases like rheumatoid arthritis, shoulder infections/fractures/dislocations, severe AC Joint separations (Grades III-VI), or allergies to corticosteroids.Check my eligibility
What is being tested?
The study compares three injections for ACJ Dysfunction: a corticosteroid injection to reduce inflammation; Platelet Rich Plasma (PRP) which uses patient's own blood components to promote healing; and Lidocaine, a local anesthetic for pain relief. Participants will be randomly assigned one of these treatments and followed up over a year.See study design
What are the potential side effects?
Possible side effects include allergic reactions at the injection site, infection risk increase due to the procedure itself, temporary increase in joint pain after injection (particularly with corticosteroids), and potential tissue damage from repeated steroid use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the 1 year period after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and the 1 year period after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)
Secondary outcome measures
EuroQoL (EQ-5D)
Global Rating of Change (GROC)
Patient Acceptable Symptom Scale (PASS)
+1 more

Trial Design

3Treatment groups
Active Control
Group I: LidocaineActive Control1 Intervention
50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.
Group II: CorticosteroidActive Control1 Intervention
50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.
Group III: Platelet Rich Plasma (PRP)Active Control1 Intervention
50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.

Find a Location

Who is running the clinical trial?

Uniformed Services University of the Health SciencesFED
119 Previous Clinical Trials
90,641 Total Patients Enrolled
The Geneva FoundationOTHER
33 Previous Clinical Trials
12,498 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
18,054 Total Patients Enrolled

Media Library

Corticosteroid Injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05161468 — Phase 4
Acromioclavicular Sprain Research Study Groups: Lidocaine, Corticosteroid, Platelet Rich Plasma (PRP)
Acromioclavicular Sprain Clinical Trial 2023: Corticosteroid Injection Highlights & Side Effects. Trial Name: NCT05161468 — Phase 4
Corticosteroid Injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05161468 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit to taking part in this experiment?

"This clinical trial is restricted to those aged between 18 and 65. However, there are 23 trials available for minors and 163 studies targeting patients above the age of retirement."

Answered by AI

What medical circumstances do doctors usually prescribe Corticosteroid for?

"Corticosteroids are a common treatment for small burns, as well as to address ulcerative colitis, transplantation and hand-related issues."

Answered by AI

Are any new participants permitted to sign up for this experiment?

"Affirmative. The clinicaltrials.gov website indicates that this investigation, initially posted on July 1st 2022 and recently adjusted on September 28th 2022, is currently recruiting patients. 150 individuals must be enrolled from 2 separate sites for the trial to commence."

Answered by AI

Are there any other explorations of Corticosteroid that have taken place?

"Corticosteroid was first researched at Hamid Ahmadieh, MD in 2005 and has since been the subject of 976 studies. At this time 162 clinical trials are underway, a majority taking place in San Antonio, Texas."

Answered by AI

What is the size of the current cohort participating in this research?

"Affirmative. Clinicaltrials.gov shows that this research project, which debuted on July 1st 2022 is currently enrolling participants. Approximately 150 subjects are needed from 2 separate medical facilities."

Answered by AI

What potential health risks do Corticosteroids pose to individuals?

"Corticosteroid has been approved, so it earned a score of 3 on our safety scale."

Answered by AI

Am I eligible to join the research project?

"The trial is open to a total of 150 individuals aged 18-65 years old suffering from acromioclavicular; sprain (strain). To be eligible, patients should meet the following requirement: Age 18-65 years."

Answered by AI
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~31 spots leftby Dec 2024