Trial Outcomes & Findings for Trigger Finger Corticosteroid Injection With and Without Local Anesthetic (NCT NCT04023695)
NCT ID: NCT04023695
Last Updated: 2019-12-18
Results Overview
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
Assessed 1 minute after injection (in clinic)
Results posted on
2019-12-18
Participant Flow
Participant milestones
| Measure |
Corticosteroid With Lidocaine With Epinephrine
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Corticosteroid with lidocaine with epinephrine: Trigger finger injection
|
Corticosteroid With Normal Saline
This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.
Corticosteroid with normal saline: Trigger finger injection
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
53
|
|
Overall Study
COMPLETED
|
57
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Corticosteroid With Lidocaine With Epinephrine
n=57 Participants
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Corticosteroid with lidocaine with epinephrine: Trigger finger injection
|
Corticosteroid With Normal Saline
n=53 Participants
This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.
Corticosteroid with normal saline: Trigger finger injection
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
n=57 Participants
|
66 years
n=53 Participants
|
64.3 years
n=110 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=57 Participants
|
3 Participants
n=53 Participants
|
5 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=57 Participants
|
50 Participants
n=53 Participants
|
105 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
57 participants
n=57 Participants
|
53 participants
n=53 Participants
|
110 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: Assessed 1 minute after injection (in clinic)Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Outcome measures
| Measure |
Corticosteroid With Lidocaine With Epinephrine
n=57 Participants
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Corticosteroid with lidocaine with epinephrine: Trigger finger injection
|
Corticosteroid With Normal Saline
n=53 Participants
This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.
Corticosteroid with normal saline: Trigger finger injection
|
|---|---|---|
|
Pain Outcome: Visual Analog Scale
|
3.5 score on a scale
Interval 0.0 to 7.0
|
2 score on a scale
Interval 0.0 to 8.0
|
PRIMARY outcome
Timeframe: Assessed after 24 hours after injection (by phone)Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Outcome measures
| Measure |
Corticosteroid With Lidocaine With Epinephrine
n=57 Participants
This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Corticosteroid with lidocaine with epinephrine: Trigger finger injection
|
Corticosteroid With Normal Saline
n=53 Participants
This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.
Corticosteroid with normal saline: Trigger finger injection
|
|---|---|---|
|
Pain Outcome: Visual Analog Scale
|
1.2 units on a scale
Interval 0.0 to 3.0
|
1 units on a scale
Interval 0.0 to 6.0
|
Adverse Events
Corticosteroid With Lidocaine With Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corticosteroid With Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place