Trigger FingerPhase 4NCT03156829
Effectiveness of Cortisone Injection and Splinting for Trigger Finger
A Phase 4 study testing Splint, Betamethasone and Splint + Cortico-steroid injection in people with Trigger Finger, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigger Finger
- What is being tested?
- Splint, Betamethasone and Splint + Cortico-steroid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2017to Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Lawson Health Research Institute
London, Ontario
Katrina Munro, 5196466100 ext. 64640, Katrina.Munro@sjhc.london.on.ca
Ruby Grewal, MD, 519-646-6100 ext. 66286, rgrewa@uwo.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Trigger Finger
- Being tested
- Splint, Betamethasone, Splint + Cortico-steroid injection
- Keywords
- splinting, steroid, cortisone, trigger digit
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SplintOther
Custom made splint
BetamethasoneDrug
Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml
Splint + Cortico-steroid injectionCombination product
Splint + Cortico-steroid injection given in combination
| Study group | Role | What they receive |
|---|---|---|
| Splint alone | Experimental | Not described Receives: Other: Splint |
| Cortico-steroid alone | Experimental | Not described Receives: Drug: Betamethasone |
| Splint and cortico-steroid combined | Experimental | Not described Receives: Combination Product: Splint + Cortico-steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of symptoms
complete relief/partial relief/no relief
Measured: 6 week
Resolution of symptoms
complete relief/partial relief/no relief
Measured: 3 month
Resolution of symptoms
complete relief/partial relief/no relief
Measured: 6 month
Resolution of symptoms
complete relief/partial relief/no relief
Measured: 1 year
Secondary outcomes (40)
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Measured: 6 week
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Measured: 3 month
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Measured: 6 month
Patients' experiences with the splint - Compliance
1 poor 2 fair 3 good 4 very good 5 excellent
Measured: 1 year
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Measured: 6 week
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Measured: 3 month
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Measured: 6 month
Patients' experiences with the splint - Comfort
1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Measured: 6 week
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Measured: 3 month
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Measured: 6 month
Pain (Visual analogue scale)
on a scale ranging from "No pain" to "Pain as bad as it could possibly be")
Measured: 1 year
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Measured: 6 weeks
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Measured: 3 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Measured: 6 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Number of times
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Measured: 6 week
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Measured: 3 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Measured: 6 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
on a scale of 0 (good) to 100 (poor)
Measured: 1 year
Grip Strength (Affected hand)
Kilogram (Kg)
Measured: 6 week
Grip Strength (Affected hand)
Kilogram (Kg)
Measured: 3 month
Grip Strength (Affected hand)
Kilogram (Kg)
Measured: 6 month
Grip Strength (Affected hand)
Kilogram (Kg)
Measured: 1 year
Grip Strength (Un-affected hand)
Kilogram (Kg)
Measured: 6 weeks
Grip Strength (Un-affected hand)
Kilogram (Kg)
Measured: 3 month
Grip Strength (Un-affected hand)
Kilogram (Kg)
Measured: 6 month
Grip Strength (Un-affected hand)
Kilogram (Kg)
Measured: 1 year
Range of motion (Extensor lag)
degrees
Measured: 6 weeks
Range of motion (Extensor lag)
degrees
Measured: 3 month
Range of motion (Extensor lag)
degrees
Measured: 6 month
Range of motion (Extensor lag)
degrees
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start27 Nov 2017
- Primary completion1 Sep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trigger FingerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruby Grewal, MD, Principal investigator, Schulich School of Medicine and Dentistry\Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156829
- Sponsor's protocol ID
- 10016406
- Status last verified
- Feb 2021
- First submitted
- 8 May 2017
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25443167Tarbhai 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.
PubMed 22189188Nimigan 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.
PubMed 16357547
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cortisone Injection and Splinting for Trigger Finger: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03156829
- Acronym / sponsor ID
- 10016406
- Conditions
- Trigger Finger
- Keywords
- splinting, steroid, cortisone, trigger digit
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Splint alone | Experimental | Other: Splint |
| Cortico-steroid alone | Experimental | Drug: Betamethasone |
| Splint and cortico-steroid combined | Experimental | Combination Product: Splint + Cortico-steroid injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SplintCustom made splint | Other | Splint alone |
| BetamethasoneCorticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml | Drug | Cortico-steroid alone |
| Splint + Cortico-steroid injectionSplint + Cortico-steroid injection given in combination | Combination product | Splint and cortico-steroid combined |
Primary outcome
Resolution of symptoms
Time frame: 6 week
complete relief/partial relief/no relief
Resolution of symptoms
Time frame: 3 month
complete relief/partial relief/no relief
Resolution of symptoms
Time frame: 6 month
complete relief/partial relief/no relief
Resolution of symptoms
Time frame: 1 year
complete relief/partial relief/no relief
40 secondary outcomes
Patients' experiences with the splint - Compliance
Time frame: 6 week
Patients' experiences with the splint - Compliance
Time frame: 3 month
Patients' experiences with the splint - Compliance
Time frame: 6 month
Patients' experiences with the splint - Compliance
Time frame: 1 year
Patients' experiences with the splint - Comfort
Time frame: 6 week
Patients' experiences with the splint - Comfort
Time frame: 3 month
Patients' experiences with the splint - Comfort
Time frame: 6 month
Patients' experiences with the splint - Comfort
Time frame: 1 year
Patients' experiences with the splint - Ease of use
Time frame: 6 week
Patients' experiences with the splint - Ease of use
Time frame: 3 month
Patients' experiences with the splint - Ease of use
Time frame: 6 month
Patients' experiences with the splint - Ease of use
Time frame: 1 year
Pain (Visual analogue scale)
Time frame: 6 week
Pain (Visual analogue scale)
Time frame: 3 month
Pain (Visual analogue scale)
Time frame: 6 month
Pain (Visual analogue scale)
Time frame: 1 year
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time frame: 6 weeks
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time frame: 3 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time frame: 6 month
Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts
Time frame: 1 year
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time frame: 6 week
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time frame: 3 month
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time frame: 6 month
Incidence of Triggering: Severity (on Greens Grading Criteria)
Time frame: 1 year
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time frame: 6 week
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time frame: 3 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time frame: 6 month
Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire
Time frame: 1 year
Grip Strength (Affected hand)
Time frame: 6 week
Grip Strength (Affected hand)
Time frame: 3 month
Grip Strength (Affected hand)
Time frame: 6 month
Grip Strength (Affected hand)
Time frame: 1 year
Grip Strength (Un-affected hand)
Time frame: 6 weeks
Grip Strength (Un-affected hand)
Time frame: 3 month
Grip Strength (Un-affected hand)
Time frame: 6 month
Grip Strength (Un-affected hand)
Time frame: 1 year
Range of motion (Extensor lag)
Time frame: 6 weeks
Range of motion (Extensor lag)
Time frame: 3 month
Range of motion (Extensor lag)
Time frame: 6 month
Range of motion (Extensor lag)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Background: PubMed 25443167Castellanos 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.
- Background: PubMed 22189188Tarbhai 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.
- Background: PubMed 16357547Nimigan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruby Grewal, MD principal investigator
Schulich School of Medicine and Dentistry\Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Splint, Betamethasone and Splint + Cortico-steroid injection in people with Trigger Finger, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina Munro (5196466100 ext. 64640, Katrina.Munro@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of symptoms (time frame: 6 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156829, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.