Trigger Finger
Conditions
Brief summary
Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.
Detailed description
The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger
Interventions
DRUGCorticosteroid with lidocaine with epinephrine
Trigger finger injection
Trigger finger injection
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years old with trigger finger
Exclusion criteria
* Preference for open trigger finger release * Not a candidate for corticosteroid injection * Contraindication to lidocaine with epinephrine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Outcome: Visual Analog Scale | Assessed 1 minute after injection (in clinic) | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid With Lidocaine With Epinephrine This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine
Corticosteroid with lidocaine with epinephrine: Trigger finger injection | 57 |
| Corticosteroid With Normal Saline This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine.
Corticosteroid with normal saline: Trigger finger injection | 53 |
| Total | 110 |
Baseline characteristics
| Characteristic | Corticosteroid With Normal Saline | Total | Corticosteroid With Lidocaine With Epinephrine |
|---|---|---|---|
| Age, Continuous | 66 years | 64.3 years | 62.7 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 53 participants | 110 participants | 57 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 50 Participants | 105 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 53 |
| other Total, other adverse events | 0 / 57 | 0 / 53 |
| serious Total, serious adverse events | 0 / 57 | 0 / 53 |
Outcome results
Primary
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Assessed 1 minute after injection (in clinic)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Corticosteroid With Lidocaine With Epinephrine | Pain Outcome: Visual Analog Scale | 3.5 score on a scale |
| Corticosteroid With Normal Saline | Pain Outcome: Visual Analog Scale | 2 score on a scale |
Primary
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Assessed after 24 hours after injection (by phone)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Corticosteroid With Lidocaine With Epinephrine | Pain Outcome: Visual Analog Scale | 1.2 units on a scale |
| Corticosteroid With Normal Saline | Pain Outcome: Visual Analog Scale | 1 units on a scale |