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

• ClinicalTrials.gov Identifier: NCT04115644
• Recruitment Status: Suspended
• First Posted: October 4, 2019
• Last Update Posted: January 22, 2021
• Sponsor: Michael Khazzam
• Information provided by (Responsible Party): Michael Khazzam, University of Texas Southwestern Medical Center

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 (placebo); 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 (Clinical Trial)
• Estimated 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
• Study Start Date: May 2015
• Estimated Primary Completion Date: November 2021
• Estimated Study Completion Date: November 2023

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Group 1 (control); will receive an injection of 5 cc 0.25% Marcaine without epinephrine	Drug: Marcaine (placebo); Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine; Other Name: Bupivacaine Hydrochloride
Experimental: Group 2 (ketorolac); will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml	Drug: Ketorolac; Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml; Other Name: Toradol; Drug: Marcaine (placebo); Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine; Other Name: Bupivacaine Hydrochloride
Group 3 (kenalog); 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); Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine; Other Name: Bupivacaine Hydrochloride; Drug: Kenalog; Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.; Other Name: Triamcinolone Acetonide

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.

Secondary Outcome Measures :

1. Single Assessment Numeric Evaluation (SANE) [ Time Frame: Baseline ]
   Measure the patient's self-reported function on a scale of 0 to 100
2. Single Assessment Numeric Evaluation (SANE) [ Time Frame: Week 6 ]
   Measure the patient's self-reported function on a scale of 0 to 100
3. Single Assessment Numeric Evaluation (SANE) [ Time Frame: Week 12 ]
   Measure the patient's self-reported function on a scale of 0 to 100
4. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline ]
   Sleep quality as measured by the Pittsburgh Sleep Quality Index
5. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 6 ]
   Sleep quality as measured by the Pittsburgh Sleep Quality Index
6. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 12 ]
   Sleep quality as measured by the Pittsburgh Sleep Quality Index
7. Short Form 12 (SF-12) [ Time Frame: Baseline ]
   General health survey as measured by the Short Form 12 (SF-12)
8. Short Form 12 (SF-12) [ Time Frame: Week 6 ]
   General health survey as measured by the Short Form 12 (SF-12)
9. Short Form 12 (SF-12) [ Time Frame: Week 12 ]
   General health survey as measured by the Short Form 12 (SF-12)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
• Patients with any bleeding disorders.
• Patients with severe renal failure.
• 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 who are allergic to aspirin, ketorolac tromethamine and other NSAIDs

Contacts and Locations

Locations

United States, Maryland

John Hopkins Shoulder & Sports Medicine

Baltimore, Maryland, United States, 21205

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

Michael Khazzam

Investigators

• Principal Investigator: Michael Khazzam, MD; UT Southwestern Medical Center

More Information

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• Responsible Party: Michael Khazzam, ASSOC PROFESSOR -Orthopaedic Surgery, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT04115644
• Other Study ID Numbers: STU 092014-097
• First Posted: October 4, 2019
• Last Update Posted: January 22, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Tendinopathy; Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Muscular Diseases; Musculoskeletal Diseases; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Ketorolac; Bupivacaine; Triamcinolone diacetate; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunosuppressive Agents; Immunologic Factors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic