Trial Outcomes & Findings for Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture (NCT NCT02421419)
NCT ID: NCT02421419
Last Updated: 2018-09-28
Results Overview
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection
Results posted on
2018-09-28
Participant Flow
Participant milestones
| Measure |
Corticosteroid Alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
11
|
9
|
|
Overall Study
COMPLETED
|
6
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Corticosteroid Alone (CS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Corticosteroid Alone (CS) Group
n=6 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
n=11 Participants
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
n=9 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
4 Participants
n=9 Participants
|
14 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
5 Participants
n=9 Participants
|
12 Participants
n=26 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
8 Participants
n=11 Participants
|
7 Participants
n=9 Participants
|
16 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=9 Participants
|
10 Participants
n=26 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
11 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
26 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injectionPopulation: VAS was collected on all study participants except for the one patient (CSS group) who was withdrawn after enrollment and before any measurements were taken.
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
Outcome measures
| Measure |
Corticosteroid Alone (CS) Group
n=6 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
n=11 Participants
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
n=8 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
VAS
VAS pre-injection
|
2.2 units on a scale
Standard Deviation 1.0
|
3.0 units on a scale
Standard Deviation 2.5
|
3.9 units on a scale
Standard Deviation 2.9
|
|
VAS
VAS 1 minute post-injection
|
2.3 units on a scale
Standard Deviation 1.2
|
2.2 units on a scale
Standard Deviation 2.6
|
4.9 units on a scale
Standard Deviation 3.4
|
|
VAS
VAS 10 minutes post-injection
|
2.1 units on a scale
Standard Deviation 2.3
|
1.2 units on a scale
Standard Deviation 1.7
|
3.3 units on a scale
Standard Deviation 2.8
|
|
VAS
VAS 6 weeks post-injection
|
1.5 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 3.7
|
4.0 units on a scale
Standard Deviation 3.8
|
|
VAS
VAS Recollection
|
5.2 units on a scale
Standard Deviation 2.3
|
6.6 units on a scale
Standard Deviation 2.5
|
5.9 units on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injectionPopulation: All participants from three groups were asked this question. Data was not collected on subject (CSS group) that withdrew from study after enrollment.
Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected.
Outcome measures
| Measure |
Corticosteroid Alone (CS) Group
n=6 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
n=11 Participants
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
n=8 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
Presence of Triggering
triggering same as before 6 wks post-injection
|
2 Participants
|
8 Participants
|
5 Participants
|
|
Presence of Triggering
Triggering frequently pre-injection
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Presence of Triggering
Triggering not at all pre-injection
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Presence of Triggering
Triggering occasionally pre-injection
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Presence of Triggering
Triggering rarely pre-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering not at all 1 minute post-injection
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Presence of Triggering
Triggering rarely 1 minute post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering occasionally 1 minute post-injection
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering frequently 1 minute post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering same as before 1 minute post-injection
|
2 Participants
|
8 Participants
|
5 Participants
|
|
Presence of Triggering
Triggering not at all 10 minutes post-injection
|
4 Participants
|
2 Participants
|
4 Participants
|
|
Presence of Triggering
Triggering rarely 10 minutes post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering occasionally 10 minutes post-injection
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering frequently 10 minutes post-injection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering same as before 10 min. post-injection
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Presence of Triggering
Triggering not at all 6 wks post-injection
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Presence of Triggering
Triggering rarely 6 wks post-injection
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering occasionally 6 weeks post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Presence of Triggering
Triggering frequently 6 wks post-injection
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient SurveyPopulation: Data collected on all subjects enrolled except for one that was withdrawn after enrollment.
A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint.
Outcome measures
| Measure |
Corticosteroid Alone (CS) Group
n=6 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
n=11 Participants
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
n=8 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
Degree of Triggering
Green classification 0 (pre-injection)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Degree of Triggering
Green classification 1 (pre-injection)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Degree of Triggering
Green classification 2 (pre-injection)
|
4 Participants
|
10 Participants
|
6 Participants
|
|
Degree of Triggering
Green classification 3 (pre-injection)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Degree of Triggering
Green Classification 4 (pre-injection)
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Degree of Triggering
Green classification 0 (6-weeks post-injection)
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Degree of Triggering
Green classification 1 (6-weeks post-injection)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Degree of Triggering
Green classification 2 (6-weeks post-injection)
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Degree of Triggering
Green classification 3 (6-weeks post-injection)
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Degree of Triggering
Green classification 4 (6-weeks post-injection)
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.Population: Adverse effects was collected on all study participants except for the one patient who was withdrawn after enrollment (CSS group)
Incidence of adverse effects
Outcome measures
| Measure |
Corticosteroid Alone (CS) Group
n=6 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
|
Corticosteroid/Lidocaine (CSL) Group
n=11 Participants
1 cc dexamethasone sodium phosphate (4 mg/ml) injectable and 1 cc 1% Xylocaine (lidocaine) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Xylocaine: a local anesthetic agent
|
Corticosteroid/Saline (CSS) Group
n=8 Participants
1 cc dexamethasone sodium phosphate (4mg/ml) injectable and 1 cc 0.9% injectable Sodium Chloride (saline)
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug
Sodium Chloride: Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
|
|---|---|---|---|
|
Number of Participants With Adverse Effects
Adverse effects 1 minute post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Effects
Adverse effects 10 minutes post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Effects
Adverse effects 6 weeks post-injection
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Corticosteroid Alone (CS) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corticosteroid/Lidocaine (CSL) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Corticosteroid/Saline (CSS) Group
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
Kenneth Taylor, M.D.
Penn State Milton S. Hershey Medical Center
Phone: (717) 531-5638
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place