Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the functional outcomes of patients with shoulder pathology treated with either ketorolac or corticosteroid injections, in a randomized double-blinded study. Investigators will compare the effectiveness of ketorolac compared to corticosteroid. Specific Aim 1: Hypothesis 1: Injection of the shoulder (in the subacromial space) with Ketorolac will be more effective than corticosteroid injection for the treatment of a variety of shoulder pathologies. The risks associated with this study primarily concern adverse reactions to the study drugs. The drugs used in this study are not narcotics or habit-forming but can have side effects. The patient's physician will screen for any heart, intestinal, or kidney disease or condition that would increase the chance for the patient to have an unwanted side effect.

Detailed Description
-----------------
The proposed study is a three arm, double-blinded, prospective randomized controlled clinical trial with follow-up immediately after the injection and at day 2, and weeks 1, 2, 4, 6, and 12. In this study investigators will compare the effectiveness of ketorolac compared to corticosteroid. Subjects being seen for a rotator cuff injury will be randomized into one of three treatment groups pertaining to their pathology. The intervention will begin once the subject has consented and answered the Baseline Outcome Shoulder Questionnaire. The Baseline Outcome Questionnaire consists of the Visual Analog Score, American Shoulder and Elbow Score, Single Assessment Numeric Evaluation, Pittsburgh Sleep Quality Index, Short Form-12, and questions pertaining to patient characteristics, injury characteristics, co-morbidities, patient history, medications, and demographics.

Official Title
-----------------
Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial

Conditions
-----------------
Full-thickness Rotator Cuff Tear, Rotator Cuff Tendinitis

Intervention / Treatment
-----------------
* Drug: Ketorolac
* Drug: Marcaine
* Drug: Kenalog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: > or = 18 years old Rotator Cuff Tendinitis Atraumatic Full-thickness Rotator Cuff Tear Subjects who speak English Women who are of non-childbearing potential Exclusion Criteria: Age: < 18 years old Prior Shoulder Surgery Fracture Acute Traumatic Rotator Cuff Tear Infection Uncontrolled Diabetes Mellitus (HbA1c >8) Uncontrolled High Blood Pressure (Hypertension) Recent Prior Shoulder Injection in either the Subacromial space Workers Compensation History of Peptic Ulcer disease (includes both Gastric and Duodenal Ulcers), Gastrointestinal perforation, Inflammatory Bowel disease (Ulcerative Colitis, Crohn's disease), or any other gastrointestinal pathology Tumor Involving the Shoulder Region Prior history of gastrointestinal bleeding, allergic reactions, impaired renal function, seizures or cardiac arrhythmias Subject unable to provide informed consent Subjects who don't speak English Patients who are pregnant or lactating at time of screening or are of pregnant bearing age Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response. Patients taking any anti-platelet agents, warfarin or other anticoagulants, or SSRIs. Patients with any bleeding disorders such as coagulopathy, hypercoagulable state, or platelet disorders including thrombocytopenia. Patients with cardiac disease such as congestive heart failure, coronary artery disease, or myocardial infarction. Patients with severe renal failure. Patients with severe liver impairment or active liver disease. Patients with heavy alcohol use; this is defined as consuming 8 or more drinks per week for a woman and 15 or more drinks per week for a man. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations. Patients with a known hypersensitivity to bupivacaine or other local anesthetic agent of the amide-type. Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs. Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 (marcaine)<br>will receive an injection of 4 cc 0.25% Marcaine without epinephrine | Drug: Marcaine<br>* Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine<br>* Other names: Bupivacaine Hydrochloride;|
| Experimental: Group 2 (ketorolac)<br>will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1 | Drug: Ketorolac<br>* Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1<br>* Other names: Toradol;Drug: Marcaine<br>* Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine<br>* Other names: Bupivacaine Hydrochloride;|
| Other: Group 3 (kenalog)<br>4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care | Drug: Marcaine<br>* Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine<br>* Other names: Bupivacaine Hydrochloride;Drug: Kenalog<br>* Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.<br>* Other names: Triamcinolone Acetonide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale | Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Baseline - pre-injection | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Baseline - immediately after the injection | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Day 2 | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Week 1 | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Week 2 | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Week 4 | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Week 6 | 
| Visual Analog Scale | Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain. | Week 12 | 
| American Shoulder and Elbow Score (ASES) | Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome. | Baseline | 
| American Shoulder and Elbow Score (ASES) | Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome. | Week 6 | 
| American Shoulder and Elbow Score (ASES) | Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Assessment Numeric Evaluation (SANE) | Measure the patient's self-reported function on a scale of 0 to 100 | Baseline | 
| Single Assessment Numeric Evaluation (SANE) | Measure the patient's self-reported function on a scale of 0 to 100 | Week 6 | 
| Single Assessment Numeric Evaluation (SANE) | Measure the patient's self-reported function on a scale of 0 to 100 | Week 12 | 
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality as measured by the Pittsburgh Sleep Quality Index | Baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality as measured by the Pittsburgh Sleep Quality Index | Week 6 | 
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality as measured by the Pittsburgh Sleep Quality Index | Week 12 | 
| Short Form 12 (SF-12) | General health survey as measured by the Short Form 12 (SF-12) | Baseline | 
| Short Form 12 (SF-12) | General health survey as measured by the Short Form 12 (SF-12) | Week 6 | 
| Short Form 12 (SF-12) | General health survey as measured by the Short Form 12 (SF-12) | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder, Rotator Cuff