Trial Outcomes & Findings for Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections (NCT NCT04900220)
NCT ID: NCT04900220
Last Updated: 2023-06-23
Results Overview
Recorded when subject reports pain. 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
66 participants
Primary outcome timeframe
Up to 7 days
Results posted on
2023-06-23
Participant Flow
Patients seen in the Hand Clinic for single trigger finger issues were approached for the project.
Participant milestones
| Measure |
Betamethasone
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Betamethasone
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Betamethasone
n=32 Participants
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
n=32 Participants
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Hand Dominance
Left
|
3 Participants
n=32 Participants
|
5 Participants
n=32 Participants
|
8 Participants
n=64 Participants
|
|
Side of Trigger
Right
|
20 Participants
n=32 Participants
|
20 Participants
n=32 Participants
|
40 Participants
n=64 Participants
|
|
Side of Trigger
Left
|
12 Participants
n=32 Participants
|
12 Participants
n=32 Participants
|
24 Participants
n=64 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 12.7 • n=32 Participants
|
58.5 years
STANDARD_DEVIATION 12.6 • n=32 Participants
|
60.9 years
STANDARD_DEVIATION 12.8 • n=64 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=32 Participants
|
23 Participants
n=32 Participants
|
41 Participants
n=64 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=32 Participants
|
9 Participants
n=32 Participants
|
23 Participants
n=64 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
32 participants
n=32 Participants
|
64 participants
n=64 Participants
|
|
Tobacco Use
Smokers
|
4 Participants
n=32 Participants
|
2 Participants
n=32 Participants
|
6 Participants
n=64 Participants
|
|
Tobacco Use
Non-Smokers
|
28 Participants
n=32 Participants
|
30 Participants
n=32 Participants
|
58 Participants
n=64 Participants
|
|
Hand Dominance
Right
|
29 Participants
n=32 Participants
|
27 Participants
n=32 Participants
|
56 Participants
n=64 Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysRecorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Outcome measures
| Measure |
Betamethasone
n=32 Participants
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
n=32 Participants
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
|---|---|---|
|
Incidence of Pain
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to 7 daysAssessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Outcome measures
| Measure |
Betamethasone
n=32 Participants
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
n=32 Participants
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
|---|---|---|
|
Intensity of Pain
Baseline
|
2.8 score on a scale
Interval 0.0 to 10.0
|
2.1 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Five Minutes
|
0.3 score on a scale
Interval 0.0 to 10.0
|
0.8 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 1
|
1.4 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 2
|
1.3 score on a scale
Interval 0.0 to 10.0
|
2.1 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 3
|
1.0 score on a scale
Interval 0.0 to 10.0
|
1.5 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 4
|
0.7 score on a scale
Interval 0.0 to 10.0
|
1.0 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 5
|
0.6 score on a scale
Interval 0.0 to 10.0
|
0.8 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 6
|
0.6 score on a scale
Interval 0.0 to 10.0
|
0.7 score on a scale
Interval 0.0 to 10.0
|
|
Intensity of Pain
Day 7
|
0.5 score on a scale
Interval 0.0 to 10.0
|
0.6 score on a scale
Interval 0.0 to 10.0
|
PRIMARY outcome
Timeframe: From baseline up to 7 daysNumber of patients having a severe flare reaction
Outcome measures
| Measure |
Betamethasone
n=32 Participants
betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
|
Methylprednisolone
n=32 Participants
methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
|
|---|---|---|
|
Incidence of Flare Reaction
No Severe Flare
|
30 Participants
|
27 Participants
|
|
Incidence of Flare Reaction
Severe Flare
|
2 Participants
|
5 Participants
|
Adverse Events
Betamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Methylprednisolone
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
Dr. Shafic Sraj - Associate Professor
West Virginia University
Phone: 304-293-3007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place