Effectiveness of Corticosteroid vs Ketorolac Shoulder Injections

NCT04895280 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STU-2021-0232
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Full-thickness Rotator Cuff Tear; Rotator Cuff Tendinitis

Keywords

Shoulder; Rotator Cuff

Outcome Measures

Primary Outcomes (11)

• Visual Analog Scale

  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

  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

  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

  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

  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

  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

  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

  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)

  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)

  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)

  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 Outcomes (9)

• Single Assessment Numeric Evaluation (SANE)

  Baseline

• Single Assessment Numeric Evaluation (SANE)

  Week 6

• Single Assessment Numeric Evaluation (SANE)

  Week 12

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Week 6

Study Arms (3)

Group 1 (marcaine)

OTHER

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

Drug: Marcaine

Group 2 (ketorolac)

EXPERIMENTAL

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

Drug: Ketorolac; Drug: Marcaine

Group 3 (kenalog)

OTHER

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

Drug: Marcaine; Drug: Kenalog

Interventions

Ketorolac DRUG

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

Also known as: Toradol

Group 2 (ketorolac)

Marcaine DRUG

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

Also known as: Bupivacaine Hydrochloride

Group 1 (marcaine); Group 2 (ketorolac); Group 3 (kenalog)

Kenalog DRUG

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

Also known as: Triamcinolone Acetonide

Group 3 (kenalog)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Khazzam: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Ketorolac; Ketorolac Tromethamine; Bupivacaine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michael Khazzam, MD

  214-645-3300

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOC PROFESSOR -Orthopaedic Surgery

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 20, 2021
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)