Corticosteroid

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of AC joint pain

Tender to palpation over the AC joint that reproduces the specific pain they are seeking care for

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthe 1 year period after enrollment

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

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

Select...

You are a TRICARE eligible beneficiary (active duty, dependents, and military retired) and your main complaint is shoulder pain in the AC joint area.

Select...

You have pain in a specific area of your shoulder that gets worse when it is touched.

Select...

You have undergone tests that recreated the exact pain you are seeking treatment for.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the 1 year period after enrollment

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.

0 / 3Eligibility criteria met

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 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

Recent research and studies

Clinics in Sports MedicineJournal

Complications of the Treatment of the Acromioclavicular and Sternoclavicular Joint Injuries, Including Instability

Lemos, Mark J, and Eric T Tolo. 2003. “Complications of the Treatment of the Acromioclavicular and Sternoclavicular Joint Injuries, Including Instability”. Clinics in Sports Medicine. Elsevier BV. doi:10.1016/s0278-5919(02)00102-3.

Physical Medicine and Rehabilitation Clinics of North AmericaJournal

Platelet-rich Plasma

Wu, Peter I-Kung, Robert Diaz, and Joanne Borg-Stein. 2016. “Platelet-rich Plasma”. Physical Medicine and Rehabilitation Clinics of North America. Elsevier BV. doi:10.1016/j.pmr.2016.06.002.

Clinical RheumatologyJournal

Palpation Versus Ultrasound-guided Corticosteroid Injections and Short-term Effect in the Distal Radioulnar Joint Disorder: A Randomized, Prospective Single-blinded Study

Nam, Sang Hyun, Jongwoo Kim, Ji Hae Lee, Jaeki Ahn, Young Joo Kim, and Yongbum Park. 2013. “Palpation Versus Ultrasound-guided Corticosteroid Injections and Short-term Effect in the Distal Radioulnar Joint Disorder: A Randomized, Prospective Single-blinded Study”. Clinical Rheumatology. Springer Science and Business Media LLC. doi:10.1007/s10067-013-2355-7.

The Physician and SportsmedicineJournal