Pain Increases After Shoulder Injection

Study Overview
=================
Brief Summary
-----------------
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.

Detailed Description
-----------------
Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space. Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.

Official Title
-----------------
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Drug: Methylprednisolone (MPA)
* Drug: Triamcinolone Acetonide (TA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subacromial or glenohumeral shoulder pain to be treated with steroid injection Fluent in written and oral English Willing and able to provide written consent Willing to complete follow up pain scores (visual analog score) Exclusion Criteria: Unable to provide written consent Chronic pain syndrome Unwilling to complete follow up pain scores (visual analog score)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone acetate (MPA)<br>subacromial or glenohumeral shoulder injection | Drug: Methylprednisolone (MPA)<br>* injection into subacromial or glenohumeral space with MPA<br>* Other names: depomedrol;|
| Active Comparator: triamcinolone acetonide (TA)<br>subacromial or glenohumeral shoulder injection | Drug: Triamcinolone Acetonide (TA)<br>* injection into subacromial or glenohumeral space with TA<br>* Other names: kenalog;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of a Flare Reaction | A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain. | Post-injection day 1 through 7 |