Trial Outcomes & Findings for Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone (NCT NCT03641508)

Results Overview

Number of participants with no symptoms of trigger finger 6 weeks after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

69 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Triamcinolone The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
First Injection STARTED	37	32
First Injection COMPLETED	35	32
First Injection NOT COMPLETED	2	0
Follow-up/Second Injection STARTED	2	10
Follow-up/Second Injection COMPLETED	2	10
Follow-up/Second Injection NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Triamcinolone The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
First Injection Lost to Follow-up	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triamcinolone n=37 Participants The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone n=32 Participants The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine	Total n=69 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 8.55 • n=37 Participants	63.7 years STANDARD_DEVIATION 11.37 • n=32 Participants	61.94 years STANDARD_DEVIATION 10.02 • n=69 Participants
Sex: Female, Male Female	27 Participants n=37 Participants	26 Participants n=32 Participants	53 Participants n=69 Participants
Sex: Female, Male Male	10 Participants n=37 Participants	6 Participants n=32 Participants	16 Participants n=69 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	37 participants n=37 Participants	32 participants n=32 Participants	69 participants n=69 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of participants with no symptoms of trigger finger 6 weeks after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Outcome measures

Outcome measures
Measure	Triamcinolone n=35 Participants The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone n=32 Participants The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Number of Participants With no Symptoms of Trigger Finger	28 Participants	9 Participants

PRIMARY outcome

Timeframe: 6 months

Number of participants with no symptoms of trigger finger 6 months after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Outcome measures

Outcome measures
Measure	Triamcinolone n=35 Participants The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone n=32 Participants The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Number of Participants With no Symptoms of Trigger Finger	23 Participants	12 Participants

PRIMARY outcome

Timeframe: 1 year

Number of participants with no symptoms of trigger finger 1 year after the initial encounter for both groups. Outcomes were determined clinically: The Quinnell grading system was used for objectively evaluating the trigger finger. This grading system is a scale of 0-4 for severity of triggering with 0 being no triggering.

Outcome measures

Outcome measures
Measure	Triamcinolone n=35 Participants The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone n=32 Participants The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Number of Participants With no Symptoms of Trigger Finger	20 Participants	13 Participants

Adverse Events

Triamcinolone

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Dexamethasone

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Triamcinolone n=37 participants at risk The study drug used will be triamcinolone mixed with 1% lidocaine without epinephrine Triamcinolone: Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine	Dexamethasone n=32 participants at risk The study drug used will be dexamethasone mixed with 1% lidocaine without epinephrine Dexamethasone: dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
Musculoskeletal and connective tissue disorders Transient numbness	21.6% 8/37 • Number of events 8	15.6% 5/32 • Number of events 5
Skin and subcutaneous tissue disorders Pigment change	5.4% 2/37 • Number of events 2	6.2% 2/32 • Number of events 2

Additional Information

Dr. Ericka Lawler

University of Iowa

Phone: 3193563943

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place