Full Thickness Rotator Cuff Tear, Rotator Cuff Tendinitis
Conditions
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.
Interventions
DRUGKetorolac
Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
DRUGMarcaine (placebo)
Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
DRUGKenalog
Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
Sponsors
Michael Khazzam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 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. |
| American Shoulder and Elbow Score (ASES) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Assessment Numeric Evaluation (SANE) | Baseline | Measure the patient's self-reported function on a scale of 0 to 100 |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline | Sleep quality as measured by the Pittsburgh Sleep Quality Index |
| Short Form 12 (SF-12) | Baseline | General health survey as measured by the Short Form 12 (SF-12) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Control) will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine | 26 |
| Group 2 (Ketorolac) will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Ketorolac: Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine | 30 |
| 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
Marcaine (placebo): Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
Kenalog: Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone. | 26 |
| Total | 82 |
Baseline characteristics
| Characteristic | Group 1 (Control) | Group 2 (Ketorolac) | Group 3 (Kenalog) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 13 Participants | 15 Participants | 34 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 17 Participants | 11 Participants | 48 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 17 Participants | 21 Participants | 22 Participants | 60 Participants |
| Sex: Female, Male Female | 9 Participants | 22 Participants | 17 Participants | 48 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 9 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 30 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 30 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 30 | 0 / 26 |
Outcome results
Primary
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.
Time frame: Baseline
Population: Data were not collected.
Primary
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.
Time frame: Week 12
Population: Data were not collected.
Primary
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.
Time frame: Week 6
Population: Data were not collected.
Primary
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.
Time frame: Baseline - immediately after the injection
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.197 score on a scale | Standard Deviation 2.9 |
| Group 2 (Ketorolac) | Visual Analog Scale | 3.577 score on a scale | Standard Deviation 2.5 |
| Group 3 (Kenalog) | Visual Analog Scale | 3.677 score on a scale | Standard Deviation 2.5 |
Primary
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.
Time frame: Baseline - pre-injection
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 5.77 score on a scale | Standard Deviation 2.6 |
| Group 2 (Ketorolac) | Visual Analog Scale | 4.57 score on a scale | Standard Deviation 2.4 |
| Group 3 (Kenalog) | Visual Analog Scale | 4.67 score on a scale | Standard Deviation 1.9 |
Primary
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.
Time frame: Day 2
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 2.347 score on a scale | Standard Deviation 1.9 |
| Group 2 (Ketorolac) | Visual Analog Scale | 2.837 score on a scale | Standard Deviation 1.8 |
| Group 3 (Kenalog) | Visual Analog Scale | 2.67 score on a scale | Standard Deviation 1.7 |
Primary
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.
Time frame: Week 1
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.397 score on a scale | Standard Deviation 3 |
| Group 2 (Ketorolac) | Visual Analog Scale | 3.7 score on a scale | Standard Deviation 1.7 |
| Group 3 (Kenalog) | Visual Analog Scale | 3.257 score on a scale | Standard Deviation 2.2 |
Primary
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.
Time frame: Week 2
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.547 score on a scale | Standard Deviation 2.8 |
| Group 2 (Ketorolac) | Visual Analog Scale | 2.67 score on a scale | Standard Deviation 1.9 |
| Group 3 (Kenalog) | Visual Analog Scale | 2.57 score on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: Week 4
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.547 score on a scale | Standard Deviation 2.8 |
| Group 2 (Ketorolac) | Visual Analog Scale | 2.67 score on a scale | Standard Deviation 1.9 |
| Group 3 (Kenalog) | Visual Analog Scale | 2.317 score on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: Week 6
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.357 score on a scale | Standard Deviation 3.2 |
| Group 2 (Ketorolac) | Visual Analog Scale | 2.757 score on a scale | Standard Deviation 2.5 |
| Group 3 (Kenalog) | Visual Analog Scale | 2.687 score on a scale | Standard Deviation 2.1 |
Primary
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.
Time frame: Week 12
Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Control) | Visual Analog Scale | 3.447 score on a scale | Standard Deviation 2.6 |
| Group 2 (Ketorolac) | Visual Analog Scale | 1.417 score on a scale | Standard Deviation 1.5 |
| Group 3 (Kenalog) | Visual Analog Scale | 2.027 score on a scale | Standard Deviation 1.9 |
Secondary
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Week 6
Population: Data were not collected.
Secondary
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Baseline
Population: Data were not collected.
Secondary
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Time frame: Week 12
Population: Data were not collected.
Secondary
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Baseline
Population: Data were not collected.
Secondary
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Week 6
Population: Data were not collected.
Secondary
Short Form 12 (SF-12)
General health survey as measured by the Short Form 12 (SF-12)
Time frame: Week 12
Population: Data were not collected.
Secondary
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Baseline
Population: Data were not collected.
Secondary
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Week 12
Population: Data were not collected.
Secondary
Single Assessment Numeric Evaluation (SANE)
Measure the patient's self-reported function on a scale of 0 to 100
Time frame: Week 6
Population: Data were not collected.