Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
NCT ID: NCT04115644
Last Updated: 2023-12-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
82 participants
INTERVENTIONAL
2017-05-01
2017-09-14
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 (control)
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Marcaine (placebo)
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Group 2 (ketorolac)
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Ketorolac
Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Marcaine (placebo)
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Group 3 (kenalog)
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
Marcaine (placebo)
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Kenalog
Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Interventions
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Ketorolac
Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Marcaine (placebo)
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Kenalog
Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Atraumatic Rotator Cuff Tear
* Rotator Cuff Tear Arthropathy
* Subjects who speak English
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Michael Khazzam
OTHER
Responsible Party
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Michael Khazzam
PROFESSOR -Orthopaedic Surgery
Principal Investigators
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Michael Khazzam, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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John Hopkins Shoulder & Sports Medicine
Baltimore, Maryland, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STU 092014-097
Identifier Type: -
Identifier Source: org_study_id