Clinical trial NCT04895280: Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections
Official title: Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Full-thickness Rotator Cuff Tear
Rotator Cuff Tendinitis
Keywords: Shoulder
Rotator Cuff
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Baseline - pre-injection
measure: Visual Analog Scale
timeFrame: Baseline - immediately after the injection
measure: Visual Analog Scale
timeFrame: Day 2
measure: Visual Analog Scale
timeFrame: Week 1
measure: Visual Analog Scale
timeFrame: Week 2
measure: Visual Analog Scale
timeFrame: Week 4
measure: Visual Analog Scale
timeFrame: Week 6
measure: Visual Analog Scale
timeFrame: Week 12
measure: American Shoulder and Elbow Score (ASES)
timeFrame: Baseline
measure: American Shoulder and Elbow Score (ASES)
timeFrame: Week 6
measure: American Shoulder and Elbow Score (ASES)
timeFrame: Week 12
Secondary outcomes:
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Baseline
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Week 6
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: Week 12
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 6
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 12
measure: Short Form 12 (SF-12)
timeFrame: Baseline
measure: Short Form 12 (SF-12)
timeFrame: Week 6
measure: Short Form 12 (SF-12)
timeFrame: Week 12
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: 214-645-3300
name: Michael Khazzam, MD
role: PRINCIPAL_INVESTIGATOR
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