Status:
TERMINATED
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Lead Sponsor:
Michael Khazzam
Conditions:
Full Thickness Rotator Cuff Tear
Rotator Cuff Tendinitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. In...
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 s...
Eligibility Criteria
Inclusion
- Rotator Cuff Tendinitis
- Atraumatic Rotator Cuff Tear
- Rotator Cuff Tear Arthropathy
- Subjects who speak English
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04115644
Start Date
May 1 2017
End Date
September 14 2017
Last Update
December 14 2023
Active Locations (2)
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1
John Hopkins Shoulder & Sports Medicine
Baltimore, Maryland, United States, 21205
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390