Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-03-14 @ 5:31 AM
Study NCT ID:
NCT05161468
Status:
TERMINATED
Last Update Posted:
2025-05-14
First Post:
2021-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platelet-rich Plasma, Corticosteroid, or Lidocaine for Acromioclavicular Joint Pain
Sponsor:
Brooke Army Medical Center
Organization:
Study Overview
Official Title:
Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding limitation did not allow the trial to run to completion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Subjects with a diagnosis of AC joint dysfunction will be recruited through the primary care and orthopaedic clinics at participating hospitals and clinics. 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. The primary outcome will be the change in PROMIS Physical Function Scale at 6 months post-enrollment. Secondary outcomes will include additional time points (viz, 1, 2, 3, 4, 5, and 12 months post-enrollment) and additional metrics (eg, AUC) as well as the PROMIS Pain Interference, Patient Acceptable Symptom State, Global Rating of Change, total limited duty days, and perceived recovery. Since the sample size is too small to establish non-inferiority by traditional hypothesis testing, a fully Bayesian approach will be used.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: