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Effectiveness of Cortisone Injection and Splinting for Trigger Finger

Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03156829
Enrollment
120
Registered
2017-05-17
Start date
2017-11-27
Completion date
2022-09-30
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trigger Finger

Keywords

splinting, steroid, cortisone, trigger digit

Brief summary

Trigger finger has a prevalence rate of up to 3%. There are many approaches available to manage this condition. While corticosteroid injection is widely accepted as the most common first-line treatment, its superiority over splint treatment has not been established. This study aims to test the effectiveness of cortisone injections, splint and cortisone+splint to resolve symptoms.

Detailed description

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.

Interventions

OTHERSplint

Custom made splint

DRUGBetamethasone

Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml

COMBINATION_PRODUCTSplint + Cortico-steroid injection

Splint + Cortico-steroid injection given in combination

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Skeletally mature adults 2. Symptom duration of at least 3 months 3. Diagnosis of trigger finger: based on history of triggering and physical examination (pain over the flexor tendon, tenderness or nodule over the A1 pulley, stiffness, and reproducible locking or triggering). 4. Green's Grade 1-3 (Green's Classification to Grade the Severity of Trigger Finger)

Exclusion criteria

1. Congenital trigger thumb 2. Green's Grade 4 (fixed flexion contracture) 3. Previous treatment for trigger finger (injection or surgery) 4. Allergy to cortisone 5. Multiple digits (\>2 digits)

Design outcomes

Primary

MeasureTime frameDescription
Resolution of symptoms6 weekcomplete relief/partial relief/no relief

Secondary

MeasureTime frameDescription
Patients' experiences with the splint - Comfort6 week1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Patients' experiences with the splint - Ease of use6 week1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Pain (Visual analogue scale)6 weekon a scale ranging from No pain to Pain as bad as it could possibly be)
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts6 weeksNumber of times
Patients' experiences with the splint - Compliance6 week1 poor 2 fair 3 good 4 very good 5 excellent
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire6 weekon a scale of 0 (good) to 100 (poor)
Grip Strength (Affected hand)6 weekKilogram (Kg)
Grip Strength (Un-affected hand)6 weeksKilogram (Kg)
Range of motion (Extensor lag)6 weeksdegrees
Incidence of Triggering: Severity (on Greens Grading Criteria)6 weekGrade 1: Pain/history of catching Grade 2: Demonstrate catching, but can actively extend the digit Grade 3: Demonstrate locking, requiring passive extension Grade 4: Fixed flexion contracture

Countries

Canada

Contacts

Primary ContactKatrina Munro
Katrina.Munro@sjhc.london.on.ca5196466100
Backup ContactRuby Grewal, MD
rgrewa@uwo.ca519-646-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026