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

Phase 4

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Age: < 18 years old
Prior Shoulder Surgery
Fracture
Acute Traumatic Rotator Cuff Tear
Infection
Uncontrolled Diabetes Mellitus (HbA1c >8)
Recent Prior Shoulder Injection in either the Subacromial space
Workers Compensation
History of Gastric Ulcers
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 child bearing age
Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
Patients with any bleeding disorders.
Patients with severe renal failure.
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 who are allergic to aspirin, ketorolac tromethamine and other NSAIDs

Arm && Interventions

Group	Intervention	Description
Group 3 (kenalog)	Marcaine (placebo)	Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
Group 1 (control)	Marcaine (placebo)	will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Group 2 (ketorolac)	Marcaine (placebo)	will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Group 2 (ketorolac)	Ketorolac	will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Group 3 (kenalog)	Kenalog	Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Score (ASES)	Week 12	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.
Visual Analog Scale	Week 12	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.

Secondary Outcome Measures

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

Locations (2): University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
John Hopkins Shoulder & Sports Medicine
🇺🇸
Baltimore, Maryland, United States