Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age: > or = 18 years old.
  • - Rotator Cuff Tendinitis.
  • - Atraumatic Full-thickness Rotator Cuff Tear.
  • - Subjects who speak English.
  • - Women who are of non-childbearing potential.

Exclusion Criteria:

  • - Age: < 18 years old.
  • - Prior Shoulder Surgery.
  • - Fracture.
  • - Acute Traumatic Rotator Cuff Tear.
  • - Infection.
  • - Uncontrolled Diabetes Mellitus (HbA1c >8) - Uncontrolled High Blood Pressure (Hypertension) - Recent Prior Shoulder Injection in either the Subacromial space Workers Compensation.
  • - 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.
  • - 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 pregnant bearing age.
  • - Patients currently receiving an aspirin, NSAID regimen or any other anti-inflammatory agents that could affect inflammation response.
  • - Patients taking any anti-platelet agents, warfarin or other anticoagulants, or SSRIs.
  • - Patients with any bleeding disorders such as coagulopathy, hypercoagulable state, or platelet disorders including thrombocytopenia.
  • - Patients with cardiac disease such as congestive heart failure, coronary artery disease, or myocardial infarction.
  • - Patients with severe renal failure.
Patients with severe liver impairment or active liver disease.
  • - Patients with heavy alcohol use; this is defined as consuming 8 or more drinks per week for a woman and 15 or more drinks per week for a man.
  • - 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 with a known hypersensitivity to bupivacaine or other local anesthetic agent of the amide-type.
  • - Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
  • - Patients who are allergic to aspirin, ketorolac tromethamine and other NSAIDs.
  • - Patients who are currently on probenecid or pentoxifylline as described in the approved label of Ketorolac tromethamine injection.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04895280
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Michael Khazzam
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Khazzam, MD
Principal Investigator Affiliation 214-645-3300
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Full-thickness Rotator Cuff Tear, Rotator Cuff Tendinitis
Additional Details

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 study investigators will compare the effectiveness of ketorolac compared to corticosteroid. 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.

Arms & Interventions

Arms

Other: Group 1 (marcaine)

will receive an injection of 4 cc 0.25% Marcaine without epinephrine

Experimental: Group 2 (ketorolac)

will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1

Other: Group 3 (kenalog)

4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care

Interventions

Drug: - Ketorolac

Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1

Drug: - Marcaine

Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine

Drug: - Kenalog

Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Site Contact

Cynthia Wright

[email protected]

214-645-0423