Effectiveness of Cortisone Injection and Splinting for Trigger Finger

February 25, 2021 updated by: Lawson Health Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ruby Grewal, MD
  • Phone Number: 66286 519-646-6100
  • Email: rgrewa@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Recruiting
        • Lawson Health Research Institute
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resolution of symptoms
Time Frame: 6 week
complete relief/partial relief/no relief
6 week
Resolution of symptoms
Time Frame: 3 month
complete relief/partial relief/no relief
3 month
Resolution of symptoms
Time Frame: 6 month
complete relief/partial relief/no relief
6 month
Resolution of symptoms
Time Frame: 1 year
complete relief/partial relief/no relief
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients' experiences with the splint - Compliance
Time Frame: 6 week
1 poor 2 fair 3 good 4 very good 5 excellent
6 week
Patients' experiences with the splint - Compliance
Time Frame: 3 month
1 poor 2 fair 3 good 4 very good 5 excellent
3 month
Patients' experiences with the splint - Compliance
Time Frame: 6 month
1 poor 2 fair 3 good 4 very good 5 excellent
6 month
Patients' experiences with the splint - Compliance
Time Frame: 1 year
1 poor 2 fair 3 good 4 very good 5 excellent
1 year
Patients' experiences with the splint - Comfort
Time Frame: 6 week
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
6 week
Patients' experiences with the splint - Comfort
Time Frame: 3 month
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
3 month
Patients' experiences with the splint - Comfort
Time Frame: 6 month
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
6 month
Patients' experiences with the splint - Comfort
Time Frame: 1 year
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
1 year
Patients' experiences with the splint - Ease of use
Time Frame: 6 week
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
Time Frame: 3 month
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
Time Frame: 6 month
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
Time Frame: 1 year
1 Very difficult 2 Difficult 3 Neutral 4 Easy to use 5 Very easy to use
1 year
Pain (Visual analogue scale)
Time Frame: 6 week
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
6 week
Pain (Visual analogue scale)
Time Frame: 3 month
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
3 month
Pain (Visual analogue scale)
Time Frame: 6 month
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
6 month
Pain (Visual analogue scale)
Time Frame: 1 year
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
Time Frame: 6 weeks
Number of times
6 weeks
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time Frame: 3 month
Number of times
3 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time Frame: 6 month
Number of times
6 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time Frame: 1 year
Number of times
1 year
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time Frame: 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
6 week
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time Frame: 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
3 month
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time Frame: 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
6 month
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time Frame: 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
1 year
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time Frame: 6 week
on a scale of 0 (good) to 100 (poor)
6 week
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time Frame: 3 month
on a scale of 0 (good) to 100 (poor)
3 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time Frame: 6 month
on a scale of 0 (good) to 100 (poor)
6 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time Frame: 1 year
on a scale of 0 (good) to 100 (poor)
1 year
Grip Strength (Affected hand)
Time Frame: 6 week
Kilogram (Kg)
6 week
Grip Strength (Affected hand)
Time Frame: 3 month
Kilogram (Kg)
3 month
Grip Strength (Affected hand)
Time Frame: 6 month
Kilogram (Kg)
6 month
Grip Strength (Affected hand)
Time Frame: 1 year
Kilogram (Kg)
1 year
Grip Strength (Un-affected hand)
Time Frame: 6 weeks
Kilogram (Kg)
6 weeks
Grip Strength (Un-affected hand)
Time Frame: 3 month
Kilogram (Kg)
3 month
Grip Strength (Un-affected hand)
Time Frame: 6 month
Kilogram (Kg)
6 month
Grip Strength (Un-affected hand)
Time Frame: 1 year
Kilogram (Kg)
1 year
Range of motion (Extensor lag)
Time Frame: 6 weeks
degrees
6 weeks
Range of motion (Extensor lag)
Time Frame: 3 month
degrees
3 month
Range of motion (Extensor lag)
Time Frame: 6 month
degrees
6 month
Range of motion (Extensor lag)
Time Frame: 1 year
degrees
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lawson Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruby Grewal, MD, Schulich School of Medicine and Dentistry\Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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