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Long Term Effectiveness of Trigger Finger Injections With Triamcinolone vs. Dexamethasone

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ClinicalTrials.gov Identifier: NCT03641508
Recruitment Status : Completed
First Posted : August 22, 2018
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Ericka Lawler, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Trigger Finger Disorder
Interventions Drug: Triamcinolone
Drug: Dexamethasone
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triamcinolone Dexamethasone
Hide Arm/Group Description

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

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

Period Title: First Injection
Started 37 32
Completed 35 32
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             2             0
Period Title: Follow-up/Second Injection
Started [1] 2 10 [1]
Completed 2 [1] 10 [1]
Not Completed 0 0
[1]
Only those who had symptoms at the six-week follow-up received the second injection
Arm/Group Title Triamcinolone Dexamethasone Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 37 32 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 32 participants 69 participants
60.4  (8.55) 63.7  (11.37) 61.94  (10.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 32 participants 69 participants
Female
27
  73.0%
26
  81.3%
53
  76.8%
Male
10
  27.0%
6
  18.8%
16
  23.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 32 participants 69 participants
37 32 69
1.Primary Outcome
Title Number of Participants With no Symptoms of Trigger Finger
Hide Description

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.

Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Dexamethasone
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 35 32
Measure Type: Count of Participants
Unit of Measure: Participants
28
  80.0%
9
  28.1%
2.Primary Outcome
Title Number of Participants With no Symptoms of Trigger Finger
Hide Description

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.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Dexamethasone
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 35 32
Measure Type: Count of Participants
Unit of Measure: Participants
23
  65.7%
12
  37.5%
3.Primary Outcome
Title Number of Participants With no Symptoms of Trigger Finger
Hide Description

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.

Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Triamcinolone Dexamethasone
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 35 32
Measure Type: Count of Participants
Unit of Measure: Participants
20
  57.1%
13
  40.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Triamcinolone Dexamethasone
Hide Arm/Group Description

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

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

All-Cause Mortality
Triamcinolone Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Triamcinolone Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Triamcinolone Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/37 (27.03%)      7/32 (21.88%)    
Musculoskeletal and connective tissue disorders     
Transient numbness *  8/37 (21.62%)  8 5/32 (15.63%)  5
Skin and subcutaneous tissue disorders     
Pigment change *  2/37 (5.41%)  2 2/32 (6.25%)  2
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ericka Lawler
Organization: University of Iowa
Phone: 3193563943
Publications:
Wolfe, Scott W. "Chapter 62—Tendinopathy." Green's Operative Hand Surgery, 6th Ed. Elsevier, Philadelphia. 2011.
Responsible Party: Ericka Lawler, University of Iowa
ClinicalTrials.gov Identifier: NCT03641508     History of Changes
Other Study ID Numbers: 201308766
First Submitted: August 4, 2017
First Posted: August 22, 2018
Results First Submitted: September 19, 2018
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019