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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • 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

    Recruiting

Other trials in Canada

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 groups in NCT03156829
Study groupRoleWhat they receive
Splint aloneExperimentalNot described
Receives: Other: Splint
Cortico-steroid aloneExperimentalNot described
Receives: Drug: Betamethasone
Splint and cortico-steroid combinedExperimentalNot 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.

  1. Resolution of symptoms

    complete relief/partial relief/no relief

    Measured: 6 week

  2. Resolution of symptoms

    complete relief/partial relief/no relief

    Measured: 3 month

  3. Resolution of symptoms

    complete relief/partial relief/no relief

    Measured: 6 month

  4. Resolution of symptoms

    complete relief/partial relief/no relief

    Measured: 1 year

Secondary outcomes (40)
  1. Patients' experiences with the splint - Compliance

    1 poor 2 fair 3 good 4 very good 5 excellent

    Measured: 6 week

  2. Patients' experiences with the splint - Compliance

    1 poor 2 fair 3 good 4 very good 5 excellent

    Measured: 3 month

  3. Patients' experiences with the splint - Compliance

    1 poor 2 fair 3 good 4 very good 5 excellent

    Measured: 6 month

  4. Patients' experiences with the splint - Compliance

    1 poor 2 fair 3 good 4 very good 5 excellent

    Measured: 1 year

  5. Patients' experiences with the splint - Comfort

    1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable

    Measured: 6 week

  6. Patients' experiences with the splint - Comfort

    1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable

    Measured: 3 month

  7. Patients' experiences with the splint - Comfort

    1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable

    Measured: 6 month

  8. Patients' experiences with the splint - Comfort

    1 very uncomfortable 2 uncomfortable 3 neither 4 comfortable 5 comfortable

    Measured: 1 year

  9. 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

  10. 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

  11. 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

  12. 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

  13. Pain (Visual analogue scale)

    on a scale ranging from "No pain" to "Pain as bad as it could possibly be")

    Measured: 6 week

  14. Pain (Visual analogue scale)

    on a scale ranging from "No pain" to "Pain as bad as it could possibly be")

    Measured: 3 month

  15. Pain (Visual analogue scale)

    on a scale ranging from "No pain" to "Pain as bad as it could possibly be")

    Measured: 6 month

  16. Pain (Visual analogue scale)

    on a scale ranging from "No pain" to "Pain as bad as it could possibly be")

    Measured: 1 year

  17. Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts

    Number of times

    Measured: 6 weeks

  18. Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts

    Number of times

    Measured: 3 month

  19. Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts

    Number of times

    Measured: 6 month

  20. Incidence of Triggering: Number of times finger 'catches' with 10 repeated grip attempts

    Number of times

    Measured: 1 year

  21. 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

  22. 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

  23. 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

  24. 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

  25. Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire

    on a scale of 0 (good) to 100 (poor)

    Measured: 6 week

  26. Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire

    on a scale of 0 (good) to 100 (poor)

    Measured: 3 month

  27. Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire

    on a scale of 0 (good) to 100 (poor)

    Measured: 6 month

  28. Patient Rated Wrist Hand Evaluation (PRWHE) - self reported questionnaire

    on a scale of 0 (good) to 100 (poor)

    Measured: 1 year

  29. Grip Strength (Affected hand)

    Kilogram (Kg)

    Measured: 6 week

  30. Grip Strength (Affected hand)

    Kilogram (Kg)

    Measured: 3 month

  31. Grip Strength (Affected hand)

    Kilogram (Kg)

    Measured: 6 month

  32. Grip Strength (Affected hand)

    Kilogram (Kg)

    Measured: 1 year

  33. Grip Strength (Un-affected hand)

    Kilogram (Kg)

    Measured: 6 weeks

  34. Grip Strength (Un-affected hand)

    Kilogram (Kg)

    Measured: 3 month

  35. Grip Strength (Un-affected hand)

    Kilogram (Kg)

    Measured: 6 month

  36. Grip Strength (Un-affected hand)

    Kilogram (Kg)

    Measured: 1 year

  37. Range of motion (Extensor lag)

    degrees

    Measured: 6 weeks

  38. Range of motion (Extensor lag)

    degrees

    Measured: 3 month

  39. Range of motion (Extensor lag)

    degrees

    Measured: 6 month

  40. 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.

  1. First posted17 May 2017
  2. Study start27 Nov 2017
  3. Primary completion1 Sep 2021 (estimated)
  4. Study completionSep 2022 (estimated)

Resources

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)
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 25443167
  • 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.

    PubMed 22189188
  • 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.

    PubMed 16357547

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.

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Clinical Trial NCT03156829 | AzTrials