Effectiveness of Cortisone Injection and Splinting for Trigger Finger
Primary Purpose
Trigger Finger
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Splint
Betamethasone
Splint + Cortico-steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Trigger Finger focused on measuring splinting, steroid, cortisone, trigger digit
Eligibility 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)
Sites / Locations
- Lawson Health Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Splint alone
Cortico-steroid alone
Splint and cortico-steroid combined
Arm Description
Outcomes
Primary Outcome Measures
Resolution of symptoms
complete relief/partial relief/no relief
Resolution of symptoms
complete relief/partial relief/no relief
Resolution of symptoms
complete relief/partial relief/no relief
Resolution of symptoms
complete relief/partial relief/no relief
Secondary Outcome Measures
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Patients' experiences with the splint - Ease of use
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 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Patients' experiences with the splint - Ease of use
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 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Pain (Visual analogue scale)
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
Number of times
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
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
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
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
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
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Grip Strength (Affected hand)
Kilogram (Kg)
Grip Strength (Affected hand)
Kilogram (Kg)
Grip Strength (Affected hand)
Kilogram (Kg)
Grip Strength (Affected hand)
Kilogram (Kg)
Grip Strength (Un-affected hand)
Kilogram (Kg)
Grip Strength (Un-affected hand)
Kilogram (Kg)
Grip Strength (Un-affected hand)
Kilogram (Kg)
Grip Strength (Un-affected hand)
Kilogram (Kg)
Range of motion (Extensor lag)
degrees
Range of motion (Extensor lag)
degrees
Range of motion (Extensor lag)
degrees
Range of motion (Extensor lag)
degrees
Full Information
NCT ID
NCT03156829
First Posted
May 8, 2017
Last Updated
February 25, 2021
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03156829
Brief Title
Effectiveness of Cortisone Injection and Splinting for Trigger Finger
Official Title
Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger
Keywords
splinting, steroid, cortisone, trigger digit
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Splint alone
Arm Type
Experimental
Arm Title
Cortico-steroid alone
Arm Type
Experimental
Arm Title
Splint and cortico-steroid combined
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Splint
Intervention Description
Custom made splint
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Description
Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml
Intervention Type
Combination Product
Intervention Name(s)
Splint + Cortico-steroid injection
Intervention Description
Splint + Cortico-steroid injection given in combination
Primary Outcome Measure Information:
Title
Resolution of symptoms
Description
complete relief/partial relief/no relief
Time Frame
6 week
Title
Resolution of symptoms
Description
complete relief/partial relief/no relief
Time Frame
3 month
Title
Resolution of symptoms
Description
complete relief/partial relief/no relief
Time Frame
6 month
Title
Resolution of symptoms
Description
complete relief/partial relief/no relief
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patients' experiences with the splint - Compliance
Description
1 poor 2 fair 3 good 4 very good 5 excellent
Time Frame
6 week
Title
Patients' experiences with the splint - Compliance
Description
1 poor 2 fair 3 good 4 very good 5 excellent
Time Frame
3 month
Title
Patients' experiences with the splint - Compliance
Description
1 poor 2 fair 3 good 4 very good 5 excellent
Time Frame
6 month
Title
Patients' experiences with the splint - Compliance
Description
1 poor 2 fair 3 good 4 very good 5 excellent
Time Frame
1 year
Title
Patients' experiences with the splint - Comfort
Description
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Time Frame
6 week
Title
Patients' experiences with the splint - Comfort
Description
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Time Frame
3 month
Title
Patients' experiences with the splint - Comfort
Description
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Time Frame
6 month
Title
Patients' experiences with the splint - Comfort
Description
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Time Frame
1 year
Title
Patients' experiences with the splint - Ease of use
Description
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Time Frame
6 week
Title
Patients' experiences with the splint - Ease of use
Description
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Time Frame
3 month
Title
Patients' experiences with the splint - Ease of use
Description
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Time Frame
6 month
Title
Patients' experiences with the splint - Ease of use
Description
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
Time Frame
1 year
Title
Pain (Visual analogue scale)
Description
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Time Frame
6 week
Title
Pain (Visual analogue scale)
Description
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Time Frame
3 month
Title
Pain (Visual analogue scale)
Description
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Time Frame
6 month
Title
Pain (Visual analogue scale)
Description
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Time Frame
1 year
Title
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Description
Number of times
Time Frame
6 weeks
Title
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Description
Number of times
Time Frame
3 month
Title
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Description
Number of times
Time Frame
6 month
Title
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Description
Number of times
Time Frame
1 year
Title
Incidence of Triggering: Severity (on Greens Grading Criteria)
Description
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
Time Frame
6 week
Title
Incidence of Triggering: Severity (on Greens Grading Criteria)
Description
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
Time Frame
3 month
Title
Incidence of Triggering: Severity (on Greens Grading Criteria)
Description
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
Time Frame
6 month
Title
Incidence of Triggering: Severity (on Greens Grading Criteria)
Description
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
Time Frame
1 year
Title
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Description
on a scale of 0 (good) to 100 (poor)
Time Frame
6 week
Title
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Description
on a scale of 0 (good) to 100 (poor)
Time Frame
3 month
Title
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Description
on a scale of 0 (good) to 100 (poor)
Time Frame
6 month
Title
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Description
on a scale of 0 (good) to 100 (poor)
Time Frame
1 year
Title
Grip Strength (Affected hand)
Description
Kilogram (Kg)
Time Frame
6 week
Title
Grip Strength (Affected hand)
Description
Kilogram (Kg)
Time Frame
3 month
Title
Grip Strength (Affected hand)
Description
Kilogram (Kg)
Time Frame
6 month
Title
Grip Strength (Affected hand)
Description
Kilogram (Kg)
Time Frame
1 year
Title
Grip Strength (Un-affected hand)
Description
Kilogram (Kg)
Time Frame
6 weeks
Title
Grip Strength (Un-affected hand)
Description
Kilogram (Kg)
Time Frame
3 month
Title
Grip Strength (Un-affected hand)
Description
Kilogram (Kg)
Time Frame
6 month
Title
Grip Strength (Un-affected hand)
Description
Kilogram (Kg)
Time Frame
1 year
Title
Range of motion (Extensor lag)
Description
degrees
Time Frame
6 weeks
Title
Range of motion (Extensor lag)
Description
degrees
Time Frame
3 month
Title
Range of motion (Extensor lag)
Description
degrees
Time Frame
6 month
Title
Range of motion (Extensor lag)
Description
degrees
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Munro
Phone
5196466100
Ext
64640
Email
Katrina.Munro@sjhc.london.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Ruby Grewal, MD
Phone
519-646-6100
Ext
66286
Email
rgrewa@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Grewal, MD
Organizational Affiliation
Schulich School of Medicine and Dentistry\Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Munro
Phone
5196466100
Ext
64640
Email
Katrina.Munro@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Ruby Grewal, MD
Phone
519-646-6100
Ext
66286
Email
rgrewa@uwo.ca
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD
First Name & Middle Initial & Last Name & Degree
Nina Suh, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25443167
Citation
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.
Results Reference
background
PubMed Identifier
22189188
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.
Results Reference
background
PubMed Identifier
16357547
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. doi: 10.1097/01.phm.0000184236.81774.b5.
Results Reference
background
Learn more about this trial
Effectiveness of Cortisone Injection and Splinting for Trigger Finger
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