Trial Outcomes & Findings for Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis (NCT NCT04002037)
NCT ID: NCT04002037
Last Updated: 2024-06-26
Results Overview
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
TERMINATED
PHASE4
95 participants
6 Weeks
2024-06-26
Participant Flow
Participant milestones
| Measure |
Triamcinolone 40mg/mL
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
43
|
28
|
|
Overall Study
COMPLETED
|
24
|
43
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Differential Efficacy of Corticosteroid Solutions for Non-Operative Treatment of Digit Flexor Tenosynovitis
Baseline characteristics by cohort
| Measure |
Triamcinolone 40mg/mL
n=24 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=43 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=28 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.54 years
STANDARD_DEVIATION 9.99 • n=93 Participants
|
63.77 years
STANDARD_DEVIATION 10.65 • n=4 Participants
|
61.75 years
STANDARD_DEVIATION 9.11 • n=27 Participants
|
63.37 years
STANDARD_DEVIATION 0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=12 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=27 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=16 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH)
|
12.69 score on a scale
Standard Deviation 19.87
|
18.69 score on a scale
Standard Deviation 18.73
|
24.72 score on a scale
Standard Deviation 13.74
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=13 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=24 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=12 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH)
|
17.66 score on a scale
Standard Deviation 19.88
|
18.09 score on a scale
Standard Deviation 17.71
|
23.38 score on a scale
Standard Deviation 22.91
|
PRIMARY outcome
Timeframe: 6 MonthPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to complete a questionnaire with questions related to their hand. Their answers will be scored on a scale of 0-100 with 0 being no disability and 100 being the highest level of disability.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=13 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=30 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=14 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Disabilities of the Arm, Shoulder and Hand (DASH)
|
22.73 score on a scale
Standard Deviation 19.53
|
22.12 score on a scale
Standard Deviation 20.55
|
13.64 score on a scale
Standard Deviation 16.24
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=12 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=27 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=14 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Pain Visual Analog Score (VAS)
|
1.08 score on a scale
Standard Deviation 2.15
|
1.33 score on a scale
Standard Deviation 2.2
|
2.04 score on a scale
Standard Deviation 2.09
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=13 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=24 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=15 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Pain Visual Analog Score (VAS)
|
1.15 score on a scale
Standard Deviation 1.91
|
2.38 score on a scale
Standard Deviation 2.37
|
3.33 score on a scale
Standard Deviation 3.22
|
PRIMARY outcome
Timeframe: 6 MonthPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
The patient will be asked to report their pain on a scale of 0 - 10 using the Visual Analog Scale with 0 being no pain and 10 being the worst pain the patient can imagine.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=15 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=29 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=16 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Pain Visual Analog Score (VAS)
|
1.53 score on a scale
Standard Deviation 1.46
|
1.97 score on a scale
Standard Deviation 2.41
|
1.38 score on a scale
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=12 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=26 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=9 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
|
48.24 score on a scale
Standard Deviation 13.45
|
44.49 score on a scale
Standard Deviation 11.89
|
37.55 score on a scale
Standard Deviation 8.98
|
PRIMARY outcome
Timeframe: 12 WeeksPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=11 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=22 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=14 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
|
48.28 score on a scale
Standard Deviation 12.09
|
44.82 score on a scale
Standard Deviation 11.68
|
43.44 score on a scale
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: 6 MonthPopulation: The analysis population differs from the participant flow module due to participants not completing the outcome measure or due to early study termination.
PROMIS Physical Function - Upper Extremity is a self-reported performance measure assessing physical function of the upper extremity focusing on nine activities that require use of the upper extremity including shoulder, arm, and hand activities. Responses are as follows: 5 = Without any difficulty; 4 = With a little difficulty; 3=With some difficulty; 2=With much difficulty; and 1=Unable to do. The PROMIS Upper Extremity assessment evaluates upper extremity function, with raw scores typically ranging from 8 to 40, depending on the specific form used. These raw scores are converted to T-scores using a standardized table, with a mean of 50 and a standard deviation of 10. These T-scores range from 15 to 61. A higher T-score indicates better upper extremity function, while a lower T-score signifies greater impairment.
Outcome measures
| Measure |
Triamcinolone 40mg/mL
n=15 Participants
A corticosteroid injection of Triamcinolone 40mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 40mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Triamcinolone 10mg/mL
n=29 Participants
A corticosteroid injection of Triamcinolone 10mg/mL will be given to subjects to treat their symptoms of trigger finger.
Triamcinolone Acetonide 10mg/mL: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
Soluble Dexamethasone 4mg/mL
n=14 Participants
A corticosteroid injection of Soluble Dexamethasone 4mg/mL will be given to subjects to treat their symptoms of trigger finger.
Dexamethasone 4 mg/ml: Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
|
|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores
|
38.46 score on a scale
Standard Deviation 12.9
|
42.23 score on a scale
Standard Deviation 11.43
|
47.9 score on a scale
Standard Deviation 11.51
|
Adverse Events
Triamcinolone 40mg/mL
Triamcinolone 10mg/mL
Soluble Dexamethasone 4mg/mL
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