Trial Outcomes & Findings for Dexamethasone Versus Ketorolac Injection for the Treatment of Local Inflammatory Hand and Upper Extremity Disorders (NCT NCT02266433)

NCT ID: NCT02266433

Last Updated: 2020-11-02

Results Overview

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

245 participants

Primary outcome timeframe

Baseline

Results posted on

2020-11-02

Participant Flow

Patients will be enrolled from the private office of orthopaedic hand surgeons (Dr. Paksima and Dr. Sapienza) and the resident hand clinic at NYU Hospital for Joint Diseases held at the 23rd street clinic.

Participant milestones

Participant milestones
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.
Arm Receiving Ketorolac Injection
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Overall Study
STARTED
127
118
Overall Study
COMPLETED
68
65
Overall Study
NOT COMPLETED
59
53

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.
Arm Receiving Ketorolac Injection
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Overall Study
Lost to Follow-up
54
46
Overall Study
Withdrawal by Subject
5
7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm Receiving Dexamethasone Injection
n=127 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up.
Arm Receiving Ketorolac Injection
n=118 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Total
n=245 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=127 Participants
0 Participants
n=118 Participants
0 Participants
n=245 Participants
Age, Categorical
Between 18 and 65 years
93 Participants
n=127 Participants
88 Participants
n=118 Participants
181 Participants
n=245 Participants
Age, Categorical
>=65 years
34 Participants
n=127 Participants
30 Participants
n=118 Participants
64 Participants
n=245 Participants
Sex: Female, Male
Female
84 Participants
n=127 Participants
83 Participants
n=118 Participants
167 Participants
n=245 Participants
Sex: Female, Male
Male
43 Participants
n=127 Participants
35 Participants
n=118 Participants
78 Participants
n=245 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=86 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=88 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EQVAS Score
82.07 score on a scale
Standard Deviation 16.25
82.30 score on a scale
Standard Deviation 13.70

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=62 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=59 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EQVAS Score
82.79 score on a scale
Standard Deviation 13.48
82.56 score on a scale
Standard Deviation 13.77

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=30 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=31 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EQVAS Score
82.17 score on a scale
Standard Deviation 13.31
81.61 score on a scale
Standard Deviation 13.65

PRIMARY outcome

Timeframe: 12 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=11 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EQVAS Score
93.50 score on a scale
Standard Deviation 6.35
83.91 score on a scale
Standard Deviation 7.82

PRIMARY outcome

Timeframe: 6 months

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=14 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EQVAS Score
90.25 score on a scale
Standard Deviation 8.48
75.79 score on a scale
Standard Deviation 14.39

PRIMARY outcome

Timeframe: Baseline

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=88 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=89 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: QuickDASH Functional Scores
28.56 score on a scale
Standard Deviation 19.46
27.38 score on a scale
Standard Deviation 20.71

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=62 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=62 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: QuickDASH Functional Scores
28.73 score on a scale
Standard Deviation 20.03
27.56 score on a scale
Standard Deviation 18.75

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=32 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: QuickDASH Functional Scores
23.61 score on a scale
Standard Deviation 17.55
21.88 score on a scale
Standard Deviation 15.43

PRIMARY outcome

Timeframe: 12 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=9 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=12 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: QuickDASH Functional Scores
15.65 score on a scale
Standard Deviation 18.01
28.27 score on a scale
Standard Deviation 28.29

PRIMARY outcome

Timeframe: 6 months

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=15 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: QuickDASH Functional Scores
21.04 score on a scale
Standard Deviation 21.08
25.90 score on a scale
Standard Deviation 22.35

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=88 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=89 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
0.77 score on a scale
Standard Deviation 0.13
0.78 score on a scale
Standard Deviation 0.16

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=62 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=62 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
0.76 score on a scale
Standard Deviation 0.16
0.78 score on a scale
Standard Deviation 0.14

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=32 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
0.83 score on a scale
Standard Deviation 0.10
0.82 score on a scale
Standard Deviation 0.12

PRIMARY outcome

Timeframe: 12 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=9 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=12 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
0.87 score on a scale
Standard Deviation 0.10
0.81 score on a scale
Standard Deviation 0.19

PRIMARY outcome

Timeframe: 6 months

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=15 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: EuroQuol-5D (EQ-5D) Functional Score
0.88 score on a scale
Standard Deviation 0.10
0.77 score on a scale
Standard Deviation 0.18

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=88 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=94 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: VAS Pain Scores
5.41 score on a scale
Standard Deviation 2.65
4.79 score on a scale
Standard Deviation 2.47

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=63 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=64 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: VAS Pain Scores
4.20 score on a scale
Standard Deviation 2.74
4.48 score on a scale
Standard Deviation 2.63

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=30 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=31 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: VAS Pain Scores
4.23 score on a scale
Standard Deviation 2.72
3.53 score on a scale
Standard Deviation 2.82

PRIMARY outcome

Timeframe: 12 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=11 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: VAS Pain Scores
2.25 score on a scale
Standard Deviation 2.25
2.68 score on a scale
Standard Deviation 2.63

PRIMARY outcome

Timeframe: 6 months

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=15 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: VAS Pain Scores
1.75 score on a scale
Standard Deviation 3.49
3.07 score on a scale
Standard Deviation 3.57

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=91 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=95 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: Quinnell Grading Scores
1.67 score on a scale
Standard Deviation 0.76
1.79 score on a scale
Standard Deviation 0.86

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=65 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=60 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: Quinnell Grading Scores
1.37 score on a scale
Standard Deviation 0.89
1.55 score on a scale
Standard Deviation 1.08

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=49 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=29 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: Quinnell Grading Scores
1.63 score on a scale
Standard Deviation 1.00
1.07 score on a scale
Standard Deviation 0.87

PRIMARY outcome

Timeframe: 12 weeks

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minumum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=8 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=9 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: Quinnell Grading Scores
1.13 score on a scale
Standard Deviation 0.99
1.22 score on a scale
Standard Deviation 1.09

PRIMARY outcome

Timeframe: 6 months

Population: Certain participants withdrew or were lost to follow up, hence the decrease in number of participants analyzed in certain time-points.

The Quinnell grading system monitors for trigger symptom improvement with a range of 0 (minimum) to 4 (maximum) with a higher number corresponding to worse symptoms: 0-normal movement of finger; 1-uneven movement; 2-active correctible locking of digit; 3-passively correctible locking; 4-fixed deformity.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=7 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=12 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Trigger Finger Treatment Group: Quinnell Grading Scores
1.14 score on a scale
Standard Deviation 1.46
0.67 score on a scale
Standard Deviation 0.89

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=15 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-VAS Score
82.16 score on a scale
Standard Deviation 13.91
79.45 score on a scale
Standard Deviation 19.00

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=22 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=11 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-VAS Score
26.19 score on a scale
Standard Deviation 18.58
52.93 score on a scale
Standard Deviation 14.55

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The EuroQol-visual analogue scale (EQ-VAS) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=10 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=3 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-VAS Score
84.2 score on a scale
Standard Deviation 12.68
87.33 score on a scale
Standard Deviation 7.77

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=17 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: QuickDASH Scores
39.05 score on a scale
Standard Deviation 19.51
47.40 score on a scale
Standard Deviation 16.61

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=21 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=11 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: QuickDASH Scores
26.19 score on a scale
Standard Deviation 18.58
52.93 score on a scale
Standard Deviation 14.55

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There were not enough data points for 12-week and 6-month statistical analysis.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=11 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=3 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: QuickDASH Scores
23.61 score on a scale
Standard Deviation 16.18
68.34 score on a scale
Standard Deviation 19.64

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=17 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-5D Score
0.75 score on a scale
Standard Deviation 0.13
0.75 score on a scale
Standard Deviation 0.15

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=21 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=11 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-5D Score
0.83 score on a scale
Standard Deviation 0.1
0.71 score on a scale
Standard Deviation 0.18

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=11 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=3 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
DeQuervain's Treatment Group: EQ-5D Score
0.85 score on a scale
Standard Deviation 0.08
0.74 score on a scale
Standard Deviation 0.13

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=31 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=17 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: VAS Pain Score
7.03 score on a scale
Standard Deviation 2.02
6.94 score on a scale
Standard Deviation 1.99

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=23 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=10 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: VAS Pain Score
4.35 score on a scale
Standard Deviation 2.28
5.35 score on a scale
Standard Deviation 3.02

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants were lost to follow up, hence the decrease in number of participants analyzed in weeks 4 and 8. There was not enough data points for 12-week and 6-month statistical analysis.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
n=11 Participants
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=3 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
De Quervain's Treatment Group: VAS Pain Score
3.05 score on a scale
Standard Deviation 2.24
7.33 score on a scale
Standard Deviation 0.58

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
1 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) in Lateral Epicondyle
1 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

Clinician will examine the patient and palpate over the lateral epicondyle. Presence of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) Over Lateral Epicondyle
0 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
1 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
1 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The clinician examines the patient and asks patient to extend wrist against resistance by the clinician. Production of pain is a positive test, recorded as 1. Absence of pain is a negative test, recorded as 0. This is done at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: Participants With Pain (Positive Test) With Resisted Wrist Extension
0 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
14 score on a scale

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
8 score on a scale

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The QuickDASH (Quick - Disabilities of the Arm, Shoulder and Hand) is an 11-question standardized survey used to assess a patient's overall functional status and is widely used in the practice of orthopaedic surgery as an analog measurement of a patient's functional ability. Scores range from 0-100, with 100 being the most poor functionality and 0 being the best. This will be assessed at every visit by having the patient fill out the survey and our team calculating the score at the end of the visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: QuickDASH Functional Scores
9 score on a scale

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-5D Scores
0.83 score on a scale

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-5D Scores
0.83 score on a scale

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-5D (EuroQol five-dimension scale) is a 5 question survey with 3 potential responses per question, based on measuring a patient's overall quality of life. The responses are compiled into a numerical score ranging from 1 to -0.11, with 1 being the best and -0.11 being the worst in terms of quality of life. This survey will be administered to patients at each visit, along with the other surveys.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-5D Scores
1 score on a scale

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: VAS Pain Score
6 score on a scale

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: VAS Pain Score
4 score on a scale

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

VAS (Visual Analogue Scale) pain score is a 0-10 numerical score assessing patient's subjective level of reported pain. The higher the score, the higher and worse the pain level. This will be recorded from the patient's written response at every visit.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: VAS Pain Score
3 score on a scale

PRIMARY outcome

Timeframe: Baseline

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-VAS Score
89 score on a scale

PRIMARY outcome

Timeframe: 4 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-VAS Score
85 score on a scale

PRIMARY outcome

Timeframe: 8 weeks

Population: Certain participants withdrew or were lost to follow up, hence the lower overall number of participants analyzed and decrease in number of participants analyzed in certain time-points. Follow-up at 12-weeks and 6-months was not completed, as symptoms were resolved at week 8.

The EQ-VAS (EuroQol visual analog scale) is a vertical visual analogue scale that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.

Outcome measures

Outcome measures
Measure
Arm Receiving Dexamethasone Injection
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=1 Participants
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Lateral Epicondylitis Treatment Group: EQ-VAS Score
90 score on a scale

Adverse Events

Arm Receiving Dexamethasone Injection

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Arm Receiving Ketorolac Injection

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Arm Receiving Dexamethasone Injection
n=127 participants at risk
Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Dexamethasone will be administered as a peritendinous soft tissue injection of 1 mL of dexamethasone sodium phosphate (4mg/mL) and 0.5 mL (5mg) of 1% lidocaine Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Dexamethasone: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study. In its approved indication there use limitations for immunocompromised
Arm Receiving Ketorolac Injection
n=118 participants at risk
Ketorolac will be administered as a peritendinous soft tissue injection of 1 mL of ketorolac (30mg/mL) and 0.5 mL (5mg) of 1% lidocaine. Patients will be followed at the initial office visit, 4-weeks, 8-weeks, 12-weeks, and 6 months post injection to determine clinical response. A second injection can be given only once if the patient desires due to no clinical response at the 4 or 8-week follow-up. Ketorolac: The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
Skin and subcutaneous tissue disorders
Skin discoloration
0.79%
1/127 • Number of events 1 • 6 months
0.00%
0/118 • 6 months
Skin and subcutaneous tissue disorders
Redness and itching
0.79%
1/127 • Number of events 1 • 6 months
0.00%
0/118 • 6 months

Additional Information

Anthony Sapienza, MD / Assistant Professor

New York University School of Medicine - Division of Hand Surgery

Phone: 212 737 3301

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place