Back to resultsEffectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Primary Purpose
Full Thickness Rotator Cuff Tear, Rotator Cuff Tendinitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Marcaine (placebo)
Kenalog
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Rotator Cuff Tear
Eligibility 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
Sites / Locations
- John Hopkins Shoulder & Sports Medicine
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Other
Arm Label
Group 1 (control)
Group 2 (ketorolac)
Group 3 (kenalog)
Arm Description
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04115644
Brief Title
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Official Title
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 and we failed to submit annual report for 2017 and 2018
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 14, 2017 (Actual)
Study Completion Date
September 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Khazzam
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear, Rotator Cuff Tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 (control)
Arm Type
Placebo Comparator
Arm Description
will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Arm Title
Group 2 (ketorolac)
Arm Type
Experimental
Arm Description
will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Arm Title
Group 3 (kenalog)
Arm Type
Other
Arm Description
Pt will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. Group 3 is standard of care
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Intervention Type
Drug
Intervention Name(s)
Marcaine (placebo)
Other Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Intervention Type
Drug
Intervention Name(s)
Kenalog
Other Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Baseline - pre-injection
Title
Visual Analog Scale
Description
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.
Time Frame
Baseline - immediately after the injection
Title
Visual Analog Scale
Description
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.
Time Frame
Day 2
Title
Visual Analog Scale
Description
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.
Time Frame
Week 1
Title
Visual Analog Scale
Description
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.
Time Frame
Week 2
Title
Visual Analog Scale
Description
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.
Time Frame
Week 4
Title
Visual Analog Scale
Description
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.
Time Frame
Week 6
Title
Visual Analog Scale
Description
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.
Time Frame
Week 12
Title
American Shoulder and Elbow Score (ASES)
Description
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.
Time Frame
Baseline
Title
American Shoulder and Elbow Score (ASES)
Description
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.
Time Frame
Week 6
Title
American Shoulder and Elbow Score (ASES)
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Baseline
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Week 6
Title
Single Assessment Numeric Evaluation (SANE)
Description
Measure the patient's self-reported function on a scale of 0 to 100
Time Frame
Week 12
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Week 6
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time Frame
Week 12
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Baseline
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Week 6
Title
Short Form 12 (SF-12)
Description
General health survey as measured by the Short Form 12 (SF-12)
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Khazzam, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Hopkins Shoulder & Sports Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
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