Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded R… (NCT04115644) | Clinical Trial Compass
TerminatedPhase 4
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Stopped: Covid-19 and we failed to submit annual report for 2017 and 2018
United States82 participantsStarted 2017-05-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Rotator Cuff Tendinitis
* Atraumatic Rotator Cuff Tear
* Rotator Cuff Tear Arthropathy
* Subjects who speak English
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale
Timeframe: Baseline - pre-injection
2
Visual Analog Scale
Timeframe: Baseline - immediately after the injection