Trigger Finger
Conditions
Brief summary
Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Detailed description
Corticosteroid injections are effective non-surgical approach to treating trigger finger (stenosing tenosynovitis) with success rates reported as high as 92% after just one injection \[1\]. Among their side effects is a post-injection flare of increased pain that is attributed to crystal-induced synovitis. Reports of these flares in the literature have been rare. Recent evidence their incidence can be as high as 33%. The investigators feel it is a more common clinical issue than traditionally reported and it would be beneficial to control and reduce their incidence if possible. Two common corticosteroids used for trigger finger treatment are betamethasone and methylprednisolone. Both injections are effective in treating trigger finger and the decision of which to use in treatment is currently a matter of the current practice and physician preference. There is no literature comparing the side effects, specifically flare reactions between these two treatments. The goal through this randomized trial is to see whether there is a difference between these two corticosteroids in inducing flare reactions and if there are any differences in the peak level of pain and their duration. This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). Patients, who meet the inclusion criteria, will be instructed to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, during the injection and once a day for the following 7 days after the injection. The investigators estimate that a minimum of 30 patients in each group will be needed to achieve a minimum of 80% power and 0.05 significance. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups. Findings indicating a statistically significant difference in the incidence and/or intensity of the flare reactions would be clinically significant and would be evidence supporting the switch of current practice to one corticosteroid over the other.
Interventions
DRUGBetamethasone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
DRUGMethylprednisolone
The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a double-blinded randomized trial enrolling patients into one of the two treatment groups. The volume of the doses of steroid to be given will be standardized to 1 cc of either methylprednisolone (40 mg) or betamethasone (6 mg). We will instruct patients who meet the inclusion criteria to complete a visual analog scale (VAS) of their pain (1-10) prior to the injection, immediately after the injection, five minutes after the injection, and once a day for a minimum of 7 days after the injection. The incidence, intensity, time to peak and time to resolution of the flare reactions (defined as a 2-point increase from pre-injection pain) will be assessed and compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Single trigger injection * First time for the digit * No prior surgery on digit
Exclusion criteria
* Current oral steroid use * Rheumatoid arthritis * More than one single digit involved * Previous injection in same digit * Prior surgery on same digit * Other injections in the same clinic on the same day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pain | Up to 7 days | Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever |
| Intensity of Pain | Up to 7 days | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever |
| Incidence of Flare Reaction | From baseline up to 7 days | Number of patients having a severe flare reaction |
Countries
United States
Participant flow
Recruitment details
Patients seen in the Hand Clinic for single trigger finger issues were approached for the project.
Participants by arm
| Arm | Count |
|---|---|
| Betamethasone betamethasone
Betamethasone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg) | 32 |
| Methylprednisolone methylprednisolone
Methylprednisolone: The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg) | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Betamethasone | Methylprednisolone | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 12.7 | 58.5 years STANDARD_DEVIATION 12.6 | 60.9 years STANDARD_DEVIATION 12.8 |
| Hand Dominance Left | 3 Participants | 5 Participants | 8 Participants |
| Hand Dominance Right | 29 Participants | 27 Participants | 56 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 32 participants | 32 participants | 64 participants |
| Sex: Female, Male Female | 18 Participants | 23 Participants | 41 Participants |
| Sex: Female, Male Male | 14 Participants | 9 Participants | 23 Participants |
| Side of Trigger Left | 12 Participants | 12 Participants | 24 Participants |
| Side of Trigger Right | 20 Participants | 20 Participants | 40 Participants |
| Tobacco Use Non-Smokers | 28 Participants | 30 Participants | 58 Participants |
| Tobacco Use Smokers | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Incidence of Flare Reaction
Number of patients having a severe flare reaction
Time frame: From baseline up to 7 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Betamethasone | Incidence of Flare Reaction | Severe Flare | 2 Participants |
| Betamethasone | Incidence of Flare Reaction | No Severe Flare | 30 Participants |
| Methylprednisolone | Incidence of Flare Reaction | Severe Flare | 5 Participants |
| Methylprednisolone | Incidence of Flare Reaction | No Severe Flare | 27 Participants |
Primary
Incidence of Pain
Recorded when subject reports pain. Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Betamethasone | Incidence of Pain | 6 Participants |
| Methylprednisolone | Incidence of Pain | 11 Participants |
Primary
Intensity of Pain
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever
Time frame: Up to 7 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Betamethasone | Intensity of Pain | Five Minutes | 0.3 score on a scale |
| Betamethasone | Intensity of Pain | Day 4 | 0.7 score on a scale |
| Betamethasone | Intensity of Pain | Day 2 | 1.3 score on a scale |
| Betamethasone | Intensity of Pain | Day 5 | 0.6 score on a scale |
| Betamethasone | Intensity of Pain | Day 1 | 1.4 score on a scale |
| Betamethasone | Intensity of Pain | Day 6 | 0.6 score on a scale |
| Betamethasone | Intensity of Pain | Day 3 | 1.0 score on a scale |
| Betamethasone | Intensity of Pain | Day 7 | 0.5 score on a scale |
| Betamethasone | Intensity of Pain | Baseline | 2.8 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 7 | 0.6 score on a scale |
| Methylprednisolone | Intensity of Pain | Baseline | 2.1 score on a scale |
| Methylprednisolone | Intensity of Pain | Five Minutes | 0.8 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 1 | 2.9 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 2 | 2.1 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 3 | 1.5 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 4 | 1.0 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 5 | 0.8 score on a scale |
| Methylprednisolone | Intensity of Pain | Day 6 | 0.7 score on a scale |