Trigger Finger Disorder
Conditions
Keywords
flexor tendon entrapment, snapping finger, trigger digits, trigger thumb
Brief summary
This research is being done to compare pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
Detailed description
This is a prospective, randomized study comparing pain relief and efficacy of trigger finger injection using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus corticosteroid/saline combination.
Interventions
DRUGDexamethasone Sodium Phosphate
adreno-cortical steroid anti-inflammatory drug
DRUGXylocaine
a local anesthetic agent
DRUGSodium Chloride
Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
Sponsors
Kenneth Taylor, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-90 * Male or female (non-pregnant) * Clinically diagnosed trigger digit * Subject is able to provide voluntary, written informed consent * Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
Exclusion criteria
* Age \<18 or \>90 * Pregnant or lactating women * Non-English speaking individuals * Medication contradictions to lidocaine, corticosteroids and/or saline * Prior injection or surgery on the affected finger * Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome (CRPS) * Open wound
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | 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 | Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Triggering | Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection | 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. |
| Degree of Triggering | Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey | 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. |
| Number of Participants With Adverse Effects | Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection. | Incidence of adverse effects |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid Alone (CS) Group 1 cc dexamethasone sodium phosphate (4mg/ml) injectable
Dexamethasone Sodium Phosphate: adreno-cortical steroid anti-inflammatory drug | 6 |
| 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 | 11 |
| 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 | 9 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Corticosteroid/Lidocaine (CSL) Group | Corticosteroid/Saline (CSS) Group | Corticosteroid Alone (CS) Group |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 5 Participants | 5 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 6 Participants | 4 Participants | 4 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 26 Participants | 11 Participants | 9 Participants | 6 Participants |
| Sex: Female, Male Female | 16 Participants | 8 Participants | 7 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 11 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 0 / 11 | 0 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 11 | 0 / 8 |
Outcome results
Primary
VAS
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst).
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid Alone (CS) Group | VAS | VAS 6 weeks post-injection | 1.5 units on a scale | Standard Deviation 1.6 |
| Corticosteroid Alone (CS) Group | VAS | VAS 10 minutes post-injection | 2.1 units on a scale | Standard Deviation 2.3 |
| Corticosteroid Alone (CS) Group | VAS | VAS pre-injection | 2.2 units on a scale | Standard Deviation 1 |
| Corticosteroid Alone (CS) Group | VAS | VAS 1 minute post-injection | 2.3 units on a scale | Standard Deviation 1.2 |
| Corticosteroid Alone (CS) Group | VAS | VAS Recollection | 5.2 units on a scale | Standard Deviation 2.3 |
| Corticosteroid/Lidocaine (CSL) Group | VAS | VAS 10 minutes post-injection | 1.2 units on a scale | Standard Deviation 1.7 |
| Corticosteroid/Lidocaine (CSL) Group | VAS | VAS pre-injection | 3.0 units on a scale | Standard Deviation 2.5 |
| Corticosteroid/Lidocaine (CSL) Group | VAS | VAS 1 minute post-injection | 2.2 units on a scale | Standard Deviation 2.6 |
| Corticosteroid/Lidocaine (CSL) Group | VAS | VAS 6 weeks post-injection | 3.3 units on a scale | Standard Deviation 3.7 |
| Corticosteroid/Lidocaine (CSL) Group | VAS | VAS Recollection | 6.6 units on a scale | Standard Deviation 2.5 |
| Corticosteroid/Saline (CSS) Group | VAS | VAS Recollection | 5.9 units on a scale | Standard Deviation 3.6 |
| Corticosteroid/Saline (CSS) Group | VAS | VAS 6 weeks post-injection | 4.0 units on a scale | Standard Deviation 3.8 |
| Corticosteroid/Saline (CSS) Group | VAS | VAS pre-injection | 3.9 units on a scale | Standard Deviation 2.9 |
| Corticosteroid/Saline (CSS) Group | VAS | VAS 10 minutes post-injection | 3.3 units on a scale | Standard Deviation 2.8 |
| Corticosteroid/Saline (CSS) Group | VAS | VAS 1 minute post-injection | 4.9 units on a scale | Standard Deviation 3.4 |
Secondary
Degree of Triggering
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.
Time frame: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
Population: Data collected on all subjects enrolled except for one that was withdrawn after enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 1 (pre-injection) | 2 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 1 (6-weeks post-injection) | 0 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 0 (6-weeks post-injection) | 2 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green Classification 4 (pre-injection) | 0 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 3 (pre-injection) | 0 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 3 (6-weeks post-injection) | 2 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 2 (pre-injection) | 4 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 0 (pre-injection) | 0 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 4 (6-weeks post-injection) | 0 Participants |
| Corticosteroid Alone (CS) Group | Degree of Triggering | Green classification 2 (6-weeks post-injection) | 2 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 1 (pre-injection) | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 3 (pre-injection) | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 3 (6-weeks post-injection) | 7 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 0 (pre-injection) | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 2 (pre-injection) | 10 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green Classification 4 (pre-injection) | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 0 (6-weeks post-injection) | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 1 (6-weeks post-injection) | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 2 (6-weeks post-injection) | 2 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Degree of Triggering | Green classification 4 (6-weeks post-injection) | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 1 (pre-injection) | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 3 (pre-injection) | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 1 (6-weeks post-injection) | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 0 (pre-injection) | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 4 (6-weeks post-injection) | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 2 (pre-injection) | 6 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 2 (6-weeks post-injection) | 4 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green Classification 4 (pre-injection) | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 3 (6-weeks post-injection) | 2 Participants |
| Corticosteroid/Saline (CSS) Group | Degree of Triggering | Green classification 0 (6-weeks post-injection) | 1 Participants |
Secondary
Number of Participants With Adverse Effects
Incidence of adverse effects
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corticosteroid Alone (CS) Group | Number of Participants With Adverse Effects | Adverse effects 6 weeks post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Number of Participants With Adverse Effects | Adverse effects 10 minutes post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Number of Participants With Adverse Effects | Adverse effects 1 minute post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Number of Participants With Adverse Effects | Adverse effects 6 weeks post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Number of Participants With Adverse Effects | Adverse effects 1 minute post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Number of Participants With Adverse Effects | Adverse effects 10 minutes post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Number of Participants With Adverse Effects | Adverse effects 10 minutes post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Number of Participants With Adverse Effects | Adverse effects 1 minute post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Number of Participants With Adverse Effects | Adverse effects 6 weeks post-injection | 0 Participants |
Secondary
Presence of Triggering
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.
Time frame: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
Population: All participants from three groups were asked this question. Data was not collected on subject (CSS group) that withdrew from study after enrollment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering same as before 10 min. post-injection | 1 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering not at all 1 minute post-injection | 3 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering occasionally 10 minutes post-injection | 1 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering rarely 10 minutes post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering rarely 1 minute post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering frequently 10 minutes post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering not at all 10 minutes post-injection | 4 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering occasionally 1 minute post-injection | 1 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | triggering same as before 6 wks post-injection | 2 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering same as before 1 minute post-injection | 2 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering not at all 6 wks post-injection | 3 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering frequently 1 minute post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering occasionally 6 weeks post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering frequently pre-injection | 2 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering not at all pre-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering rarely 6 wks post-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering occasionally pre-injection | 4 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering rarely pre-injection | 0 Participants |
| Corticosteroid Alone (CS) Group | Presence of Triggering | Triggering frequently 6 wks post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering not at all 1 minute post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering not at all pre-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering occasionally pre-injection | 4 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering frequently 1 minute post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering frequently 10 minutes post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering not at all 6 wks post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering frequently pre-injection | 7 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering rarely pre-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering rarely 1 minute post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering occasionally 1 minute post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering same as before 1 minute post-injection | 8 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering not at all 10 minutes post-injection | 2 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering rarely 10 minutes post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering occasionally 10 minutes post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering same as before 10 min. post-injection | 6 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering rarely 6 wks post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering occasionally 6 weeks post-injection | 0 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | Triggering frequently 6 wks post-injection | 1 Participants |
| Corticosteroid/Lidocaine (CSL) Group | Presence of Triggering | triggering same as before 6 wks post-injection | 8 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering frequently pre-injection | 5 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering occasionally 6 weeks post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering occasionally 10 minutes post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering frequently 10 minutes post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering rarely pre-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering frequently 1 minute post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering same as before 10 min. post-injection | 4 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering not at all 6 wks post-injection | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering not at all pre-injection | 2 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering occasionally pre-injection | 1 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering occasionally 1 minute post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering rarely 6 wks post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering same as before 1 minute post-injection | 5 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering rarely 1 minute post-injection | 0 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | triggering same as before 6 wks post-injection | 5 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering not at all 10 minutes post-injection | 4 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering not at all 1 minute post-injection | 3 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering frequently 6 wks post-injection | 2 Participants |
| Corticosteroid/Saline (CSS) Group | Presence of Triggering | Triggering rarely 10 minutes post-injection | 0 Participants |