Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Study Overview
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Brief Summary
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The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.

Detailed Description
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Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.

Official Title
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Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial

Conditions
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Subacromial Impingement, Subacromial Impingement Syndrome

Intervention / Treatment
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* Drug: Ketorolac Tromethamine
* Drug: Methylprednisolone Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years Severe or recalcitrant shoulder impingement syndrome Subacromial injection is a therapeutic option Exclusion Criteria: Allergy or intolerance to steroids within less than 1 month Allergy or intolerance to NSAIDs within less than 1 month Pregnancy Breastfeeding Pre-existing asthma Uncontrolled psychiatric illness Previous shoulder injection within the past 3 months Evidence of confounding shoulder pathology on imaging History of a full-thickness rotator cuff tear Ipsilateral cervical radiculopathy Moderate to severe glenohumeral arthritis Systemic inflammatory conditions Kidney disease Liver disease Gastrointestinal ulcer Bleeding disorder Pending litigation or work-related claims related to the shoulder Previous shoulder surgery on the affected shoulder Evidence of local infection Evidence of adhesive capsulitis Evidence of shoulder instability

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%) | Drug: Ketorolac Tromethamine<br>* 2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).<br>* Other names: Toradol;|
| Active Comparator: Methylprednisolone<br>Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%) | Drug: Methylprednisolone Acetate<br>* 1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)<br>* Other names: DepoMedrol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeon (ASES) | The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Shoulder and Elbow Surgeon (ASES) | The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. | 2 weeks | 
| American Shoulder and Elbow Surgeon (ASES) | The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. | 4 weeks | 
| Range of Motion (ROM) | The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketorolac, Methylprednisolone, Subacromial impingement syndrome