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

NCT04115644 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STU 092014-097
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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

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 (control)

PLACEBO COMPARATOR

will receive an injection of 5 cc 0.25% Marcaine without epinephrine

Drug: Marcaine (placebo)

Group 2 (ketorolac)

EXPERIMENTAL

will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml

Drug: Ketorolac; Drug: Marcaine (placebo)

Group 3 (kenalog)

OTHER

Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care

Drug: Marcaine (placebo); Drug: Kenalog

Interventions

Ketorolac DRUG

Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml

Also known as: Toradol

Group 2 (ketorolac)

Marcaine (placebo) DRUG

Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine

Also known as: Bupivacaine Hydrochloride

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

Kenalog DRUG

Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.

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:

• Rotator Cuff Tendinitis
• Atraumatic Rotator Cuff Tear
• Rotator Cuff Tear Arthropathy
• Subjects who speak English

You may not qualify if:

• Age: \< 18 years old
• Prior Shoulder Surgery
• Fracture
• Acute Traumatic Rotator Cuff Tear
• Infection
• Uncontrolled Diabetes Mellitus (HbA1c \>8)
• Recent Prior Shoulder Injection in either the Subacromial space
• Workers Compensation
• History of Gastric Ulcers
• 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 child 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 (2)

John Hopkins Shoulder & Sports Medicine

Baltimore, Maryland, 21205, United States

Location

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

Results Point of Contact

• Title: Dr. Michael Khazzam
• Organization: UT Southwestern Medical Center

michael.khazzam@utsouthwestern.edu

214/645-8917

Study Officials

• Michael Khazzam, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: PROFESSOR -Orthopaedic Surgery

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: October 4, 2019
• Study Start: May 1, 2017
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: December 14, 2023
• Results First Posted: April 22, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)