Lidocaine for Acromioclavicular Sprain

Madigan Army Medical Center, Tacoma, WA
Protein Rich Plasma(PRP) Injection +2 morePhase 4RecruitingLed by Daniel Rhon, DScResearch Sponsored by Brooke Army Medical Center

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.

Eligible Conditions
  • Acromioclavicular Sprain (Strain)

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You are a TRICARE eligible beneficiary (active duty, dependents, and military retired) and your main complaint is shoulder pain in the AC joint area.
You have pain in a specific area of your shoulder that gets worse when it is touched.
You have undergone tests that recreated the exact pain you are seeking treatment for.


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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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 site

Who is running the clinical trial?

The Geneva FoundationOTHER
29 Previous Clinical Trials
12,093 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
114 Previous Clinical Trials
91,843 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
18,058 Total Patients Enrolled
Brooke Army Medical CenterLead Sponsor
115 Previous Clinical Trials
27,240 Total Patients Enrolled
Daniel Rhon, DScPrincipal Investigator
Uniformed Services University of the Health Sciences
3 Previous Clinical Trials
716 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 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. 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
Recent research and studies
~72 spots leftby Dec 2024