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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Baseline
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Week 6
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Week 12
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Week 6
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Week 12
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Baseline
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Week 6
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Week 12