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Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial

Rotator Cuff Tendinitis Clinical Trial

Official title:
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04115644
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Terminated
Phase Phase 4
Start date May 1, 2017
Completion date September 14, 2017
View Details
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