Effectiveness of Cortisone Injection and Splinting for Trigger Finger

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

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.

Study Overview

• Status: Unknown
• Conditions: Trigger Finger
• Intervention / Treatment: Other: Splint; Drug: Betamethasone; Combination product: Splint + Cortico-steroid injection

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada
      • Recruiting
      • Lawson Health Research Institute
      • Contact: Katrina Munro; Phone Number: 64640 5196466100; Email: katrina.munro@sjhc.london.on.ca
      • Contact: Ruby Grewal, MD; Phone Number: 66286 519-646-6100; Email: rgrewa@uwo.ca
      • Sub-Investigator: Joy MacDermid, PhD
      • Sub-Investigator: Nina Suh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of symptoms	complete relief/partial relief/no relief	6 week
Resolution of symptoms	complete relief/partial relief/no relief	3 month
Resolution of symptoms	complete relief/partial relief/no relief	6 month
Resolution of symptoms	complete relief/partial relief/no relief	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	6 week
Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	3 month
Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	6 month
Patients' experiences with the splint - Compliance	1 poor 2 fair 3 good 4 very good 5 excellent	1 year
Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	6 week
Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	3 month
Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	6 month
Patients' experiences with the splint - Comfort	1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable	1 year
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
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
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
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
Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	6 week
Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	3 month
Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	6 month
Pain (Visual analogue scale)	on a scale ranging from "No pain" to "Pain as bad as it could possibly be")	1 year
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	6 weeks
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	3 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	6 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts	Number of times	1 year
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
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
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
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
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	6 week
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	3 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	6 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire	on a scale of 0 (good) to 100 (poor)	1 year
Grip Strength (Affected hand)	Kilogram (Kg)	6 week
Grip Strength (Affected hand)	Kilogram (Kg)	3 month
Grip Strength (Affected hand)	Kilogram (Kg)	6 month
Grip Strength (Affected hand)	Kilogram (Kg)	1 year
Grip Strength (Un-affected hand)	Kilogram (Kg)	6 weeks
Grip Strength (Un-affected hand)	Kilogram (Kg)	3 month
Grip Strength (Un-affected hand)	Kilogram (Kg)	6 month
Grip Strength (Un-affected hand)	Kilogram (Kg)	1 year
Range of motion (Extensor lag)	degrees	6 weeks
Range of motion (Extensor lag)	degrees	3 month
Range of motion (Extensor lag)	degrees	6 month
Range of motion (Extensor lag)	degrees	1 year

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Ruby Grewal, MD, Schulich School of Medicine and Dentistry\Surgery

Publications and helpful links

General Publications

• 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.
• Castellanos J, Munoz-Mahamud E, Dominguez 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. doi: 10.1097/01.phm.0000184236.81774.b5.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 27, 2017
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: steroid; splinting; cortisone; trigger digit
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Tendon Entrapment; Trigger Finger Disorder; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 10016406

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No