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Platelet-rich Plasma, Corticosteroid, or Lidocaine for Acromioclavicular Joint Pain

NCT05161468 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-14

No results posted yet for this study

Summary

This study will compare three different treatment injections for the management of acromioclavicular joint dysfunction (ACJ Dysfunction). Patients that consent and enroll will be randomized to receive (1) a corticosteroid injection, (2) an injection of Platelet Rich Plasma, or (3) a Lidocaine injection. Follow-up will occur over a 1 year period.

Conditions

  • Acromioclavicular Sprain

Interventions

DRUG

Lidocaine injection

2ml of 1% lidocaine will be drawn into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml).

DRUG

Corticosteroid Injection

1 ml of triamcinolone acetonide (40 mg/ml) will be drawn with 1 ml normal saline into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml).

DRUG

Protein Rich Plasma(PRP) Injection

30 ml of acid-citrate-dextrose (ACD) will be drawn into a 30 ml syringe to coat the syringe. 3 ml will be left in the syringe and then 27 ml of blood will be drawn via standard venipuncture. The 30 ml mixture of blood and ACD will then be prepared in the Peak PRP system as described in the manufacturer's instruction (PEAK® PRP System). After preparation, PRP will be withdrawn (2 mls) into a 3 ml syringe and labeled. It will then be delivered into the AC joint per standard injection procedures (estimated 1-2 ml).

Sponsors & Collaborators

  • The Geneva Foundation

    collaborator OTHER

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Madigan Army Medical Center

    collaborator FED

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Daniel Rhon, DSc · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-12
Primary Completion
2025-05-12
Completion
2025-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161468 on ClinicalTrials.gov