BACKGROUND:
Multiple approaches, such as nonsteroidal anti-inflammatory medication (NSAIDs), splinting,
percutaneous surgery, and open surgery, are available for managing trigger finger, blind
corticosteroid injection has been widely accepted as the most common first-line treatment
(Castellanos 2015). Splinting is helpful in reducing symptoms, is relatively inexpensive and
has a low risk of complications, however, no concrete evidence exists to support the role of
splinting in patients presenting with trigger finger (Tarbhai 2012). Surgical intervention is
the most effective treatment; however, it is associated with higher risks and loss of time
from work (Nimigan 2006). Corticosteroid injection is considered the most effective treatment
to resolve symptoms in nondiabetic patients, as the success rate is slightly lower in
patients with diabetes (Nimigan 2006). Although there are few studies suggesting
effectiveness of cortisone injections and splinting for patients with trigger finger. There
is lack of consensus on whether cortisone injections and splinting are effective on their own
or in combination to resolve patient symptoms in the long term.
OBJECTIVE:
The objective is to prospectively compare the effectiveness of cortisone injections, splint
and cortisone+splint for complete resolution of symptoms for the entirety of the follow-up
period.
STUDY DESIGN AND METHODOLOGY:
This is a randomized controlled trial. On receipt of consent, the subjects will be screened
for eligibility criteria and informed about the study by their surgeon or their delegate,
Katrina Munro who is a research assistant working on this project. They will be informed that
if they choose to participate, they will be randomized to receive either a splint,
corticosteroid injection or both. Side effects will be explained. In keeping with standard
ethical procedures, patients will be informed about confidentiality, that their care will not
be affected by their choice, and their rights to withdraw consent at any time. Upon receiving
verbal consent, patients will sign the consent form approved by the institutional/ ethics
review board. Once a patient has consented, block randomization will occur according to the
following stratification variables: A.Severity Grade 1 (pain/history of catching) and Grade 2
(demonstrable catching, can actively extend) Grade 3 (demonstrable locking, requiring passive
extension) B. Diabetes (y/n)
DATA ANALYSIS:
Statistical Package for Social Sciences for Windows software (SPSS version 23, IBM SPSS Inc.,
Chicago, Ill., USA) for Windows (Microsoft) will be used for statistical analyses. Variables
will be expressed as mean and range or mean ± SD, as appropriate. Univariate analysis will be
used to compare clinical, and demographic data between study groups, including independent
t-test for continuous variables and chi square test for categorical variables. General linear
models with repeated measures of ANOVA and mixed model ANOVA will be used to examine the
change in outcomes within and between the participant groups respectively. Non-parametric
tests will be employed when applicable. Logistic and linear multivariate regression analysis
will be used to examine binary and continuous outcome variables respectively, controlling for
confounding variables.
