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Corticosteroid

Corticosteroid vs Ketorolac Injections for Shoulder Pain

Phase 4
Waitlist Available
Led By Michael Khazzam, MD
Research Sponsored by Michael Khazzam
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Rotator Cuff Tendinitis
Diagnosis of Atraumatic Full-thickness Rotator Cuff Tear
Must not have
Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial is looking at whether ketorolac or corticosteroid injections are more effective for shoulder pathologies.

Who is the study for?
This trial is for adults over 18 with rotator cuff tendinitis or atraumatic full-thickness rotator cuff tears, who speak English and are not of childbearing potential. Excluded are those with shoulder tumors, non-English speakers, NSAID users, allergy to NSAIDs, uncontrolled diabetes or hypertension, prior shoulder surgery or injection, bleeding disorders, severe heart disease or liver impairment.
What is being tested?
The study aims to determine if Ketorolac injections in the shoulder are more effective than corticosteroid injections for treating various shoulder pathologies. It's a randomized double-blinded trial where neither the participants nor the investigators know which treatment is being administered.
What are the potential side effects?
Potential side effects include adverse reactions specific to ketorolac and corticosteroids such as gastrointestinal issues like ulcers and bleeding; kidney problems; allergic reactions; increased risk of infection; and possibly cardiovascular events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Rotator Cuff Tendinitis.
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I have a complete tear in my shoulder's rotator cuff without any injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking probenecid or pentoxifylline as prescribed.
Select...
I have a history of stomach or intestinal ulcers, IBD, or other serious gut issues.
Select...
I have had a sudden injury causing a tear in my shoulder's rotator cuff.
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I am under 18 years old.
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My diabetes is not under control (HbA1c >8).
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I have a heart condition like heart failure or heart attack.
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My tumor is located in the shoulder area.
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I do not speak English.
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I am not pregnant, breastfeeding, or able to become pregnant.
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I have had surgery on my shoulder before.
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I have had a fracture in the past.
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I am currently taking aspirin, NSAIDs, or other anti-inflammatory drugs.
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I am currently taking blood thinners or SSRIs.
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I have severe kidney problems.
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My high blood pressure is not under control.
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I have a bleeding disorder or a condition affecting how my blood clots.
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I do not have severe liver problems or active liver disease.
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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
American Shoulder and Elbow Score (ASES)
Visual Analog Scale
Secondary study objectives
Pittsburgh Sleep Quality Index (PSQI)
Short Form 12 (SF-12)
Single Assessment Numeric Evaluation (SANE)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3 (kenalog)Experimental Treatment2 Interventions
4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care
Group II: Group 2 (ketorolac)Experimental Treatment2 Interventions
will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
Group III: Group 1 (marcaine)Experimental Treatment1 Intervention
will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760
Marcaine
2013
Completed Phase 4
~390
Kenalog
2013
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

Michael KhazzamLead Sponsor
1 Previous Clinical Trials
82 Total Patients Enrolled
Michael Khazzam, MDPrincipal Investigator214-645-3300
1 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

Kenalog (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04895280 — Phase 4
Rotator Cuff Tears Research Study Groups: Group 1 (marcaine), Group 2 (ketorolac), Group 3 (kenalog)
Rotator Cuff Tears Clinical Trial 2023: Kenalog Highlights & Side Effects. Trial Name: NCT04895280 — Phase 4
Kenalog (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895280 — Phase 4
~267 spots leftby Nov 2026
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