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

May 13, 2025 updated by: Dan Rhon, Brooke Army Medical Center

Bayesian Non-inferiority Trial of Injection Therapies for Acromioclavicular Joint Pain: a Randomized Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78219
        • Brooke Army Medical Center
    • Washington
      • Tacoma, Washington, United States, 98391
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ.
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).
Other Names:
  • xylocaine
Active Comparator: Corticosteroid
50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ.
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).
Other Names:
  • triamcinolone acetonide; glucocorticoid
Active Comparator: Platelet Rich Plasma (PRP)
50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ.
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).
Other Names:
  • acid-citrate-dextrose (ACD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcomes Measurement Information Systems (PROMIS) - Physical Function Scale Computer Adapted Test (PF-CAT)
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptable Symptom Scale (PASS)
Time Frame: 6 months
We will use the PASS as a global, dichotomized single-item score indicating if patients are satisfied with the current state of their symptoms. This tool has been validated in patients with osteoarthritis. The PASS asks the patient; "Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" Response options are "yes" or "no"
6 months
Global Rating of Change (GROC)
Time Frame: 6 months
The GROC measures changes in perceived quality of life, in a variety of pain populations. It has a 15-point scale (-7 to +7), with a 0 indicating 'about the same", a -7 indicating 'a very great deal worse', and a +7 indicating a 'a very great deal better'. A score of -2 (a little bit worse) to +2 (a little bit better) indicates a perception of no change in the condition from baseline. A+3 ('somewhat better') or higher demonstrates a clinically significant improvement.
6 months
EuroQoL (EQ-5D)
Time Frame: Baseline; 6 Months and 1 Year after Enrollment
the EQ-5D is a generic quality of life questionnaire that will assess quality of life on a scale that can be referenced to other disease conditions. The EQ-5D covers 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 response categories: level 1, "no problems"; level 2, "some problems"; and level 3, "inability or extreme problems." Responses are combined to give a 5-digit descriptive health state classification (e.g., 11222) The EQ-5D yields a total of 243 possible health states. Valuations for each health state are available. The EQ-5D is commonly used in economic evaluation of interventions and cost-effectiveness analysis.
Baseline; 6 Months and 1 Year after Enrollment
Shoulder Related Costs
Time Frame: The 1 Year Period After Enrollment
We will use the Military Data Repository (MDR) to identify shoulder-related healthcare costs over the 1-year follow-up period.
The 1 Year Period After Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

Uniformed Services University of the Health Sciences
The Geneva Foundation
Madigan Army Medical Center

Investigators

  • Principal Investigator: Daniel Rhon, DSc, Uniformed Services University of the Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2021

Primary Completion (Actual)

May 12, 2025

Study Completion (Actual)

May 12, 2025

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified research data will be shared with Military Injury Rehabilitation Research for Operational Readiness (MIRROR) and maintained indefinitely for possible use in future research.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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