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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with Rotator Cuff Tendinitis.

Select...

I have a complete tear in my shoulder's rotator cuff without any injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

American Shoulder and Elbow Score (ASES)

Visual Analog Scale

Secondary outcome measures

Pittsburgh Sleep Quality Index (PSQI)

Short Form 12 (SF-12)

Single Assessment Numeric Evaluation (SANE)

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

~400

Kenalog

2013

Completed Phase 2

~280

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Ketorolac present any serious threat to patients when used as directed?

"Ketorolac is an FDA approved medication and, as such, it received a score of 3."

Answered by AI

What is the upper limit to the amount of people who can be in this experiment?

"As of right now, this trial is not looking for any more participants. It was originally posted on October 1st, 2022 and was last updated on March 29th, 2022. However, there are presently 172 trials actively looking for patients with rotator cuff tendinitis and 205 studies for Ketorolac actively searching for patients."

Answered by AI

What medical conditions is Ketorolac effective in treating?

"While permphigus is most commonly treated with Ketorolac, this medication can also help patients manage other conditions like miosis disorder, lupus erythematosus cell, and pupil."

Answered by AI

Can you tell us about other research projects that have used Ketorolac?

"As of right now, there are 205 ongoing clinical trials studying Ketorolac's efficacy with 36 of those in the third and final stage. Most of the research is being conducted in Germantown, Tennessee, but Ketorolac is being studied at 293 different trial sites."

Answered by AI

Are new participants still being invited to join this research project?

"As of now, this study is no longer looking for additional participants. The study was originally posted on October 1st, 2022 and was last updated on March 29th, 2022. If you're interested in other trials, there are presently 172 clinical trials actively recruiting patients with rotator cuff tendinitis and 205 studies for Ketorolac actively looking for patients."

Answered by AI