Trial Outcomes & Findings for Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial (NCT NCT04115644)
NCT ID: NCT04115644
Last Updated: 2023-12-14
Results Overview
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.
TERMINATED
PHASE4
82 participants
Baseline - pre-injection
2023-12-14
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
30
|
26
|
|
Overall Study
COMPLETED
|
26
|
30
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Corticosteroid vs. Ketorolac Shoulder Injections: A Prospective Double-Blinded Randomized Trial
Baseline characteristics by cohort
| Measure |
Group 1 (Control)
n=26 Participants
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
|
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=26 Participants
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.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline - pre-injectionPopulation: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
4.57 score on a scale
Standard Deviation 2.4
|
4.67 score on a scale
Standard Deviation 1.9
|
5.77 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: Baseline - immediately after the injectionPopulation: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
3.577 score on a scale
Standard Deviation 2.5
|
3.677 score on a scale
Standard Deviation 2.5
|
3.197 score on a scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Day 2Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
2.837 score on a scale
Standard Deviation 1.8
|
2.67 score on a scale
Standard Deviation 1.7
|
2.347 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: Week 1Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
3.7 score on a scale
Standard Deviation 1.7
|
3.257 score on a scale
Standard Deviation 2.2
|
3.397 score on a scale
Standard Deviation 3.0
|
PRIMARY outcome
Timeframe: Week 2Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
2.67 score on a scale
Standard Deviation 1.9
|
2.57 score on a scale
Standard Deviation 2.1
|
3.547 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Week 4Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
2.67 score on a scale
Standard Deviation 1.9
|
2.317 score on a scale
Standard Deviation 2.1
|
3.547 score on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Week 6Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
2.757 score on a scale
Standard Deviation 2.5
|
2.687 score on a scale
Standard Deviation 2.1
|
3.357 score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: Week 12Population: For Group 3 (Kenalog), data for 1 subject was not analyzed as the subject did not complete the study.
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.
Outcome measures
| Measure |
Group 2 (Ketorolac)
n=30 Participants
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
|
Group 3 (Kenalog)
n=25 Participants
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.
|
Group 1 (Control)
n=26 Participants
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
|
|---|---|---|---|
|
Visual Analog Scale
|
1.417 score on a scale
Standard Deviation 1.5
|
2.027 score on a scale
Standard Deviation 1.9
|
3.447 score on a scale
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: BaselinePopulation: Data were not collected.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 6Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Week 12Population: Data were not collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected.
Measure the patient's self-reported function on a scale of 0 to 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected.
Measure the patient's self-reported function on a scale of 0 to 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Data were not collected.
Measure the patient's self-reported function on a scale of 0 to 100
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected.
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected.
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Data were not collected.
Sleep quality as measured by the Pittsburgh Sleep Quality Index
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: Data were not collected.
General health survey as measured by the Short Form 12 (SF-12)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: Data were not collected.
General health survey as measured by the Short Form 12 (SF-12)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 12Population: Data were not collected.
General health survey as measured by the Short Form 12 (SF-12)
Outcome measures
Outcome data not reported
Adverse Events
Group 1 (Control)
Group 2 (Ketorolac)
Group 3 (Kenalog)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place