NCT03156829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

May 8, 2017

Last Update Submit

February 25, 2021

Conditions

Trigger Finger

Keywords

splintingsteroidcortisonetrigger digit

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (40)

  • Patients' experiences with the splint - Compliance

    6 week

  • Patients' experiences with the splint - Compliance

    3 month

  • Patients' experiences with the splint - Compliance

    6 month

  • Patients' experiences with the splint - Compliance

    1 year

  • Patients' experiences with the splint - Comfort

    6 week

  • +35 more secondary outcomes

Study Arms (3)

Splint alone

EXPERIMENTAL
Other: Splint

Cortico-steroid alone

EXPERIMENTAL
Drug: Betamethasone

Splint and cortico-steroid combined

EXPERIMENTAL
Combination Product: Splint + Cortico-steroid injection

Interventions

SplintOTHER

Custom made splint

Splint alone
BetamethasoneDRUG

Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml

Cortico-steroid alone
Splint + Cortico-steroid injectionCOMBINATION_PRODUCT

Splint + Cortico-steroid injection given in combination

Splint and cortico-steroid combined

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawson Health Research Institute

London, Ontario, Canada

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25443167BACKGROUND

  • 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.

    PMID: 22189188BACKGROUND

  • 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.

    PMID: 16357547BACKGROUND

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

SplintsBetamethasone

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation DevicesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Ruby Grewal, MD

    Schulich School of Medicine and Dentistry\Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Munro

CONTACT

5196466100Katrina.Munro@sjhc.london.on.ca

Ruby Grewal, MD

CONTACT

519-646-6100rgrewa@uwo.ca

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 17, 2017

Study Start

November 27, 2017

Primary Completion

September 1, 2021

Study Completion

September 1, 2022

Last Updated

March 1, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)