Recruiting

Cortisone & Splinting

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03156829

Conditions

Trigger Finger

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Splint

Betamethasone

Splint + Cortico-steroid injection

Study Details

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.

Conditions

Trigger Finger

Study ID

NCT03156829

Start date

Nov 27, 2017

Status verified date

Feb, 2021

Completion date

Sep, 2022

Anticipated

Primary completion date

Sep 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Splint alone

experimental: Cortico-steroid alone

experimental: Splint and cortico-steroid combined

Interventions

Splint

Custom made splint

Betamethasone

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

Splint + Cortico-steroid injection

Splint + Cortico-steroid injection given in combination

Primary outcome measure

  • Resolution of symptoms [ Time Frame: 6 week ]
  • Resolution of symptoms [ Time Frame: 3 month ]
  • Resolution of symptoms [ Time Frame: 6 month ]
  • Resolution of symptoms [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Katrina Munro

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

Ruby Grewal, MD

519-646-6100rgrewa@uwo.ca

Locations

Lawson Health Research Institute

Recruiting

London, Ontario, Canada

Contacts

Katrina Munro

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

Ruby Grewal, MD

519-646-6100rgrewa@uwo.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Mar 1, 2021

Last verified

Feb, 2021

Keywords

  • splinting
  • steroid
  • cortisone
  • trigger digit

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2021-03-01.