Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

Study Overview
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Brief Summary
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This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

Detailed Description
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The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Official Title
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Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

Conditions
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Osteoarthritis of the Glenohumeral Joint

Intervention / Treatment
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* Procedure: intraarticular corticosteroid injections (IACSI)
* Drug: corticosteroid injections
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute. those who have failed previous treatment including over-the-counter analgesics and activity modification have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder. Exclusion Criteria: Patients will be excluded from the study for any of the following reasons: Post traumatic osteoarthritis Inflammatory osteoarthritis Imaging confirmed rotator cuff tear Prior ipsilateral shoulder surgery Memory loss or inability to complete study measures History of allergy to injection medications Diabetic patients with patient-reported fasting blood glucose >200 Prior injection in the ipsilateral shoulder within three months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: symptomatic primary osteoarthritis of the shoulder<br>Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder | Procedure: intraarticular corticosteroid injections (IACSI)<br>* ultrasound-guided IACSI will be administered<br>Drug: corticosteroid injections<br>* Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder<br>* Other names: Methylprednisolone, Depo-medrol;Device: Ultrasound<br>* ultrasound-guided IACSI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES Scores at Each Time Point | ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better). | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months | 
| Visual Analog Scale Scores at Each Time Point. | VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain. | Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months | 
| SST (Simple Shoulder Test) Scores at Each Time Point | SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better) | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |