NCT06137404

Brief Summary

The purpose of this research is to evaluate the effectiveness of two splint designs in conservative management of trigger finger.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress69%
Mar 2022Mar 2028

Study Start

First participant enrolled

March 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Expected
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

4.1 years

First QC Date

October 29, 2023

Last Update Submit

March 31, 2025

Conditions

Trigger Finger

Outcome Measures

Primary Outcomes (1)

  • Green's classification for trigger finger

    Green's classification is an objective outcome measure. The therapist grades the triggering by observing the finger when the patient makes a full fist. Grade I: Pain/history of catching Grade II: Demonstrable catching but can actively extend digit Grade III: Demonstrable locking, requiring passive extension Grade IV: Fixed flexion contracture Lowest score is I; highest score is IV

    12 weeks

Secondary Outcomes (1)

  • QuickDASH (Disability of Arm, Shoulder and Hand)

    12 weeks

Other Outcomes (1)

  • Visual Analogue Scale (VAS)

    12 weeks

Study Arms (2)

Splint M

ACTIVE COMPARATOR

Metacarpophalangeal joint blocking splint

Other: Splint

Splint R

EXPERIMENTAL

Relative motion extension splint

Other: Splint

Interventions

SplintOTHER

Comparison of splints for trigger finger

Splint MSplint R

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Trigger finger patient

You may not qualify if:

  • Diabetes, non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waikato Hospital

Hamilton, Waikato Region, 3204, New Zealand

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Interventions

Splints

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Aarti Parekh, B.Physio

    Waikato Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 18, 2023

Study Start

March 1, 2022

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2028

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations

NZ(1)