Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

Sponsor

Michael Khazzam (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04895280

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Full-thickness Rotator Cuff Tear Rotator Cuff Tendinitis	Drug: Ketorolac Drug: Marcaine Drug: Kenalog	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2028

Arms and Interventions

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: Ketorolac Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1 Other Names: Toradol Drug: Marcaine Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine Other Names: Bupivacaine Hydrochloride
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

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: Ketorolac

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

Other Names:

Toradol

Drug: Marcaine

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

Other Names:

Bupivacaine Hydrochloride

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

Outcome Measures

Primary Outcome Measures

Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
Visual Analog Scale [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.
American Shoulder and Elbow Score (ASES) [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.
American Shoulder and Elbow Score (ASES) [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.
American Shoulder and Elbow Score (ASES) [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.