Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

November 27, 2023 updated by: Michael Khazzam

Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections: a Prospective Double-Blinded Randomized Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group 1 (marcaine)
will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Drug: Marcaine
Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Other Names:
  • Bupivacaine Hydrochloride
Experimental: Group 2 (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
Other Names:
  • Bupivacaine Hydrochloride
Drug: Ketorolac
Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
Other Names:
  • Toradol
Other: Group 3 (kenalog)
4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1. Group 3 is standard of care
Drug: Marcaine
Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine
Other Names:
  • Bupivacaine Hydrochloride
Drug: Kenalog
Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.
Other Names:
  • Triamcinolone Acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Baseline - pre-injection
Pain as measured by the Visual Analog Scale prior to first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Baseline - pre-injection
Visual Analog Scale
Time Frame: Baseline - immediately after the injection
Pain as measured by the Visual Analog Scale after first injection. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Baseline - immediately after the injection
Visual Analog Scale
Time Frame: Day 2
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Day 2
Visual Analog Scale
Time Frame: Week 1
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Week 1
Visual Analog Scale
Time Frame: Week 2
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Week 2
Visual Analog Scale
Time Frame: Week 4
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Week 4
Visual Analog Scale
Time Frame: Week 6
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Week 6
Visual Analog Scale
Time Frame: Week 12
Pain as measured by the Visual Analog Scale. The visual analog scale is a 0-10 scale, 0 being no pain, 10 being unbearable pain.
Week 12
American Shoulder and Elbow Score (ASES)
Time Frame: Baseline
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Baseline
American Shoulder and Elbow Score (ASES)
Time Frame: Week 6
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Week 6
American Shoulder and Elbow Score (ASES)
Time Frame: Week 12
Pain, instability, and activities of daily living as measured by the American Shoulder and Elbow Score. The ASES is a 100-point scale that consists of two dimensions: pain and activities of daily living. One pain scale is worth 50 points, and activities of daily living worth 50 points. A higher score indicates a better outcome.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline
Measure the patient's self-reported function on a scale of 0 to 100
Baseline
Single Assessment Numeric Evaluation (SANE)
Time Frame: Week 6
Measure the patient's self-reported function on a scale of 0 to 100
Week 6
Single Assessment Numeric Evaluation (SANE)
Time Frame: Week 12
Measure the patient's self-reported function on a scale of 0 to 100
Week 12
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Week 6
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Week 6
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Week 12
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Week 12
Short Form 12 (SF-12)
Time Frame: Baseline
General health survey as measured by the Short Form 12 (SF-12)
Baseline
Short Form 12 (SF-12)
Time Frame: Week 6
General health survey as measured by the Short Form 12 (SF-12)
Week 6
Short Form 12 (SF-12)
Time Frame: Week 12
General health survey as measured by the Short Form 12 (SF-12)
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Khazzam

Investigators

  • Principal Investigator: Michael Khazzam, MD, 214-645-3300

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2021-0232

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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