Effectiveness of Cortisone Injection and Splinting for Trigger Finger

Trigger Finger Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03156829
• Other study ID #: 10016406
• Status: Recruiting
• Phase: Phase 4
• Start date: November 27, 2017
• Est. completion date: September 2022

Study information

• Verified date: February 2021
• Source: Lawson Health Research Institute
• Contact: Katrina Munro
• Phone: 5196466100
• Email: Katrina.Munro[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Trigger Finger
• Trigger Finger Disorder

Intervention

Other:
• Splint
Custom made splint

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

Combination Product:
• Splint + Cortico-steroid injection
Splint + Cortico-steroid injection given in combination

Locations

Country	Name	City	State
Canada	Lawson Health Research Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of symptoms	complete relief/partial relief/no relief	6 week
Primary	Resolution of symptoms	complete relief/partial relief/no relief	3 month
Primary	Resolution of symptoms	complete relief/partial relief/no relief	6 month
Primary	Resolution of symptoms	complete relief/partial relief/no relief	1 year
Secondary	Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	6 week
Secondary	Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	3 month
Secondary	Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	6 month
Secondary	Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	1 year
Secondary	Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	6 week
Secondary	Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	3 month
Secondary	Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	6 month
Secondary	Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	1 year
Secondary	Patients' experiences with the splint - Ease of use	1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use	6 week
Secondary	Patients' experiences with the splint - Ease of use	1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use	3 month
Secondary	Patients' experiences with the splint - Ease of use	1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use	6 month
Secondary	Patients' experiences with the splint - Ease of use	1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use	1 year
Secondary	Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	6 week
Secondary	Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	3 month
Secondary	Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	6 month
Secondary	Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	1 year
Secondary	Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	6 weeks
Secondary	Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	3 month
Secondary	Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	6 month
Secondary	Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	1 year
Secondary	Incidence of Triggering: Severity (on Greens Grading Criteria)	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	6 week
Secondary	Incidence of Triggering: Severity (on Greens Grading Criteria)	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	3 month
Secondary	Incidence of Triggering: Severity (on Greens Grading Criteria)	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	6 month
Secondary	Incidence of Triggering: Severity (on Greens Grading Criteria)	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	1 year
Secondary	Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	6 week
Secondary	Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	3 month
Secondary	Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	6 month
Secondary	Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	1 year
Secondary	Grip Strength (Affected hand)	Kilogram (Kg)	6 week
Secondary	Grip Strength (Affected hand)	Kilogram (Kg)	3 month
Secondary	Grip Strength (Affected hand)	Kilogram (Kg)	6 month
Secondary	Grip Strength (Affected hand)	Kilogram (Kg)	1 year
Secondary	Grip Strength (Un-affected hand)	Kilogram (Kg)	6 weeks
Secondary	Grip Strength (Un-affected hand)	Kilogram (Kg)	3 month
Secondary	Grip Strength (Un-affected hand)	Kilogram (Kg)	6 month
Secondary	Grip Strength (Un-affected hand)	Kilogram (Kg)	1 year
Secondary	Range of motion (Extensor lag)	degrees	6 weeks
Secondary	Range of motion (Extensor lag)	degrees	3 month
Secondary	Range of motion (Extensor lag)	degrees	6 month
Secondary	Range of motion (Extensor lag)	degrees	1 year