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

Study Overview
=================
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.

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

Conditions
-----------------
Acromioclavicular Sprain

Intervention / Treatment
-----------------
* Drug: Lidocaine injection
* Drug: Corticosteroid Injection
* Drug: Protein Rich Plasma(PRP) Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Bayesian regression model
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>50 Subjects will be randomized to this group and will receive a lidocaine injection in their ACJ. | Drug: Lidocaine injection<br>* 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).<br>* Other names: xylocaine;|
| Active Comparator: Corticosteroid<br>50 Subjects will be randomized to this group and will receive a corticosteroid injection in their ACJ. | Drug: Corticosteroid Injection<br>* 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).<br>* Other names: triamcinolone acetonide; glucocorticoid;|
| Active Comparator: Platelet Rich Plasma (PRP)<br>50 Subjects will be randomized to this group and will receive a PRP injection in their ACJ. | Drug: Protein Rich Plasma(PRP) Injection<br>* 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).<br>* 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) | 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) | 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) | 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acromioclavicular joint, shoulder pain, platelet rich plasma, corticosteroid