Effectiveness of Cortisone Injection and Splinting for Trigger Finger
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Splint alone
|
Other: Splint
Custom made splint
|
| Experimental: Cortico-steroid alone
|
Drug: Betamethasone
Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml
|
| Experimental: Splint and cortico-steroid combined
|
Combination Product: Splint + Cortico-steroid injection
Splint + Cortico-steroid injection given in combination
|
Outcome Measures
Primary Outcome Measures
- Resolution of symptoms [6 week]
complete relief/partial relief/no relief
- Resolution of symptoms [3 month]
complete relief/partial relief/no relief
- Resolution of symptoms [6 month]
complete relief/partial relief/no relief
- Resolution of symptoms [1 year]
complete relief/partial relief/no relief
Secondary Outcome Measures
- Patients' experiences with the splint - Compliance [6 week]
1 poor 2 fair 3 good 4 very good 5 excellent
- Patients' experiences with the splint - Compliance [3 month]
1 poor 2 fair 3 good 4 very good 5 excellent
- Patients' experiences with the splint - Compliance [6 month]
1 poor 2 fair 3 good 4 very good 5 excellent
- Patients' experiences with the splint - Compliance [1 year]
1 poor 2 fair 3 good 4 very good 5 excellent
- Patients' experiences with the splint - Comfort [6 week]
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
- Patients' experiences with the splint - Comfort [3 month]
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
- Patients' experiences with the splint - Comfort [6 month]
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
- Patients' experiences with the splint - Comfort [1 year]
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
- Patients' experiences with the splint - Ease of use [6 week]
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
- Patients' experiences with the splint - Ease of use [3 month]
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
- Patients' experiences with the splint - Ease of use [6 month]
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
- Patients' experiences with the splint - Ease of use [1 year]
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
- Pain (Visual analogue scale) [6 week]
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
- Pain (Visual analogue scale) [3 month]
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
- Pain (Visual analogue scale) [6 month]
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
- Pain (Visual analogue scale) [1 year]
on 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 attempts [6 weeks]
Number of times
- Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts [3 month]
Number of times
- Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts [6 month]
Number of times
- Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts [1 year]
Number of times
- Incidence of Triggering: Severity (on Greens Grading Criteria) [6 week]
Grade 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
- Incidence of Triggering: Severity (on Greens Grading Criteria) [3 month]
Grade 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
- Incidence of Triggering: Severity (on Greens Grading Criteria) [6 month]
Grade 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
- Incidence of Triggering: Severity (on Greens Grading Criteria) [1 year]
Grade 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
- Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire [6 week]
on a scale of 0 (good) to 100 (poor)
- Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire [3 month]
on a scale of 0 (good) to 100 (poor)
- Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire [6 month]
on a scale of 0 (good) to 100 (poor)
- Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire [1 year]
on a scale of 0 (good) to 100 (poor)
- Grip Strength (Affected hand) [6 week]
Kilogram (Kg)
- Grip Strength (Affected hand) [3 month]
Kilogram (Kg)
- Grip Strength (Affected hand) [6 month]
Kilogram (Kg)
- Grip Strength (Affected hand) [1 year]
Kilogram (Kg)
- Grip Strength (Un-affected hand) [6 weeks]
Kilogram (Kg)
- Grip Strength (Un-affected hand) [3 month]
Kilogram (Kg)
- Grip Strength (Un-affected hand) [6 month]
Kilogram (Kg)
- Grip Strength (Un-affected hand) [1 year]
Kilogram (Kg)
- Range of motion (Extensor lag) [6 weeks]
degrees
- Range of motion (Extensor lag) [3 month]
degrees
- Range of motion (Extensor lag) [6 month]
degrees
- Range of motion (Extensor lag) [1 year]
degrees
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Skeletally mature adults
-
Symptom duration of at least 3 months
-
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).
-
Green's Grade 1-3 (Green's Classification to Grade the Severity of Trigger Finger)
Exclusion Criteria:
-
Congenital trigger thumb
-
Green's Grade 4 (fixed flexion contracture)
-
Previous treatment for trigger finger (injection or surgery)
-
Allergy to cortisone
-
Multiple digits (>2 digits)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lawson Health Research Institute | London | Ontario | Canada |
Sponsors and Collaborators
- Lawson Health Research Institute
Investigators
- Principal Investigator: Ruby Grewal, MD, Schulich School of Medicine and Dentistry\Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
- Castellanos J, Muñoz-Mahamud E, Domínguez E, Del Amo P, Izquierdo O, Fillat P. Long-term effectiveness of corticosteroid injections for trigger finger and thumb. J Hand Surg Am. 2015 Jan;40(1):121-6. doi: 10.1016/j.jhsa.2014.09.006. Epub 2014 Oct 14.
- Nimigan AS, Ross DC, Gan BS. Steroid injections in the management of trigger fingers. Am J Phys Med Rehabil. 2006 Jan;85(1):36-43.
- Tarbhai K, Hannah S, von Schroeder HP. Trigger finger treatment: a comparison of 2 splint designs. J Hand Surg Am. 2012 Feb;37(2):243-9, 249.e1. doi: 10.1016/j.jhsa.2011.10.038. Epub 2011 Dec 20.
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