Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
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ClinicalTrials.gov Identifier: NCT04115644 |
Recruitment Status :
Suspended
(Covid-19 and we failed to submit annual report for 2017 and 2018)
First Posted : October 4, 2019
Last Update Posted : January 22, 2021
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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 |
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 (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 |

Arm | Intervention/treatment |
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Placebo Comparator: Group 1 (control)
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
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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
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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
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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 |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Single Assessment Numeric Evaluation (SANE) [ Time Frame: Baseline ]Measure the patient's self-reported function on a scale of 0 to 100
- Single Assessment Numeric Evaluation (SANE) [ Time Frame: Week 6 ]Measure the patient's self-reported function on a scale of 0 to 100
- Single Assessment Numeric Evaluation (SANE) [ Time Frame: Week 12 ]Measure the patient's self-reported function on a scale of 0 to 100
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline ]Sleep quality as measured by the Pittsburgh Sleep Quality Index
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 6 ]Sleep quality as measured by the Pittsburgh Sleep Quality Index
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Week 12 ]Sleep quality as measured by the Pittsburgh Sleep Quality Index
- Short Form 12 (SF-12) [ Time Frame: Baseline ]General health survey as measured by the Short Form 12 (SF-12)
- Short Form 12 (SF-12) [ Time Frame: Week 6 ]General health survey as measured by the Short Form 12 (SF-12)
- Short Form 12 (SF-12) [ Time Frame: Week 12 ]General health survey as measured by the Short Form 12 (SF-12)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115644
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 |
Principal Investigator: | Michael Khazzam, MD | UT Southwestern Medical Center |
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 Key Record Dates |
Last Update Posted: | January 22, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |