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

NCT05161468 | Terminated Phase 4 FDA Drug

• 1 other identifier: 221073
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Acromioclavicular Sprain

Keywords

acromioclavicular joint; shoulder pain; platelet rich plasma; corticosteroid

Outcome Measures

Primary Outcomes (1)

• Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)

  The PROMIS PF-CAT uses a 121-item bank to assess current self-reported capabilities related to physical activities. Like all PROMIS measures, the measure is reported on a T score metric, with a score of 50 aligning with the general population mean and a standard deviation of 10. Higher scores indicate more of the quantity being assessed.

  6 months

Secondary Outcomes (4)

• Patient Acceptable Symptom Scale (PASS)

  6 months

• Global Rating of Change (GROC)

  6 months

• EuroQoL (EQ-5D)

  Baseline; 6 Months and 1 Year after Enrollment

• Shoulder Related Costs

  The 1 Year Period After Enrollment

Study Arms (3)

Lidocaine

ACTIVE COMPARATOR

50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.

Drug: Lidocaine injection

Corticosteroid

ACTIVE COMPARATOR

50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.

Drug: Corticosteroid Injection

Platelet Rich Plasma (PRP)

ACTIVE COMPARATOR

50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.

Drug: Protein Rich Plasma(PRP) Injection

Interventions

Lidocaine injection DRUG

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).

Also known as: xylocaine

Lidocaine

Corticosteroid Injection DRUG

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).

Also known as: triamcinolone acetonide; glucocorticoid

Corticosteroid

Protein Rich Plasma(PRP) Injection DRUG

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).

Also known as: acid-citrate-dextrose (ACD)

Platelet Rich Plasma (PRP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TRICARE eligible beneficiaries (active duty, dependents, and military retired) with a primary complaint of AC joint pain.
• Age 18-65 years
• Able to speak and read English well enough to provide informed consent, follow study instructions and independently answer the questionnaires/surveys.
• Tender to palpation over the AC joint that reproduces the specific pain they are seeking care for
• Provocative test (cross-arm test, pain with push-ups, etc) that reproduces the specific pain they are here to seek care for

You may not qualify if:

• In the last year, the subject received any invasive interventions including injections (corticosteroid, hyaluronic acid, lidocaine, PRP, etc.) or surgery for the affected shoulder - specifically to the AC joint.
• Anyone separating from the military within 10 months (other than normal military retirement), pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury
• AC Joint separation that are with a severity of Grades III-VI (in most cases, these are treated surgically, although 78% of military surgeons recommended preferring conservative care for Grade III separations, and 86% recommending at least 3 months of conservative care before surgical consideration.
• Systemic Disease that could otherwise be responsible for the shoulder pain (i.e. rheumatoid arthritis, gout, or psoriatic arthritis), non-musculoskeletal conditions causing shoulder pain, personal history of neoplasm, current or recent shoulder joint infection, acute fracture or dislocation of the shoulder related to the current episode of pain, or other more likely primary musculoskeletal shoulder disorders (rotator cuff pathology, bicipital tendonitis, etc.)
• Concurrent adhesive capsulitis of the affected shoulder
• History of intolerance or allergy to corticosteroids

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• The Geneva Foundation: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Madigan Army Medical Center: collaborator

Study Sites (2)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98391, United States

Location

Related Publications (8)

• Pallis M, Cameron KL, Svoboda SJ, Owens BD. Epidemiology of acromioclavicular joint injury in young athletes. Am J Sports Med. 2012 Sep;40(9):2072-7. doi: 10.1177/0363546512450162. Epub 2012 Jun 15.

  PMID: 22707749 BACKGROUND

• Petron DJ, Hanson RW Jr. Acromioclavicular joint disorders. Curr Sports Med Rep. 2007 Oct;6(5):300-6.

  PMID: 17883965 BACKGROUND

• Park KD, Kim TK, Lee J, Lee WY, Ahn JK, Park Y. Palpation Versus Ultrasound-Guided Acromioclavicular Joint Intra-articular Corticosteroid Injections: A Retrospective Comparative Clinical Study. Pain Physician. 2015 Jul-Aug;18(4):333-41.

  PMID: 26218936 BACKGROUND

• Krill MK, Rosas S, Kwon K, Dakkak A, Nwachukwu BU, McCormick F. A concise evidence-based physical examination for diagnosis of acromioclavicular joint pathology: a systematic review. Phys Sportsmed. 2018 Feb;46(1):98-104. doi: 10.1080/00913847.2018.1413920. Epub 2017 Dec 13.

  PMID: 29210329 BACKGROUND

• Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.

  PMID: 27788903 BACKGROUND

• Schneider A, Burr R, Garbis N, Salazar D. Platelet-rich plasma and the shoulder: clinical indications and outcomes. Curr Rev Musculoskelet Med. 2018 Dec;11(4):593-597. doi: 10.1007/s12178-018-9517-9.

  PMID: 30196385 BACKGROUND

• Chahla J, Cinque ME, Piuzzi NS, Mannava S, Geeslin AG, Murray IR, Dornan GJ, Muschler GF, LaPrade RF. A Call for Standardization in Platelet-Rich Plasma Preparation Protocols and Composition Reporting: A Systematic Review of the Clinical Orthopaedic Literature. J Bone Joint Surg Am. 2017 Oct 18;99(20):1769-1779. doi: 10.2106/JBJS.16.01374.

  PMID: 29040132 BACKGROUND

• Nguyen RT, Borg-Stein J, McInnis K. Applications of platelet-rich plasma in musculoskeletal and sports medicine: an evidence-based approach. PM R. 2011 Mar;3(3):226-50. doi: 10.1016/j.pmrj.2010.11.007.

  PMID: 21402369 BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Lidocaine; Adrenal Cortex Hormones; Triamcinolone Acetonide; Glucocorticoids; Injections; acid citrate dextrose

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Daniel Rhon, DSc

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Primary Care Musculoskeletal Research Program

Model Details: Bayesian regression model

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 17, 2021
• Study Start: August 12, 2021
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)