NCT04568993

Brief Summary

This is a prospective randomized multicenterstudy focusing on PROMs after primary corticoid injection for triggerfinger with a comparison of two different injection techniques.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
26mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress72%
Oct 2020Jul 2028

First Submitted

Initial submission to the registry

September 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

April 24, 2026

Status Verified

October 1, 2025

Enrollment Period

7.1 years

First QC Date

September 23, 2020

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain after injection

    Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain"

    Four weeks

  • Impairment of finger motion

    Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment"

    Four weeks

  • Triggering

    Visual analouge scale (VAS), range 0-10, where 0 indicates "no trigger phenomenon" and 10 "Trigger phenomenon all the time/ locked finger"

    Four weeks

Secondary Outcomes (1)

  • Quick-DASH

    Four weeks

Study Arms (2)

proximal phalangeal level

EXPERIMENTAL

injection in the the tendon sheet over proximal phalanx of finger

Procedure: Proximal phalangeal level

volar MCP level

ACTIVE COMPARATOR

injection above the A1 pulley volar to the MCP joint

Drug: Volar to the MCP-joint

Interventions

Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx

proximal phalangeal level

Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint

volar MCP level

Eligibility Criteria

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

You may qualify if:

  • Triggering of one or more fingers and/or impaired active finger motion and/or pain during active finger motion
  • Localized tenderness volar to the MCP joint of the affected finger
  • The patient seeks treatment

You may not qualify if:

  • Previous treatment for triggerfinger in the finger to be treated
  • Impaired function of finger due to previous trauma/infection or other condition
  • Suspicion of other cause than triggeriinger/tendovaginitis
  • Patient not able to follow instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alingsås Lasarett/ District Hospital

Alingsås, Sweden

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant surgeon, MD, PhD

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 29, 2020

Study Start

October 1, 2020

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

April 24, 2026

Record last verified: 2025-10

Locations