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Active, not recruitingNCT04568993TriggerhappyUpdated Apr 24, 2026

The TriggerHappy Trial

An interventional study of Proximal phalangeal level and Volar to the MCP-joint in Trigger Finger, Trigger Thumb and Minimally Invasive Surgery, sponsored by Sahlgrenska University Hospital. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

This study aims to compare two different methods of corticosteroid injections in patients with triggerfinger, and to study the effects of these injections by day-to-day self-assessment by the included study persons for four weeks. The patient assess: 1. Pain 2. Motion and 3. Triggering by VAS scale every day for four weeks.

02

Conditions studied

  • Trigger Finger
  • Trigger Thumb
  • Minimally Invasive Surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:•

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

Exclusion Criteria:

  1. Previous treatment for triggerfinger in the finger to be treated
  2. Impaired function of finger due to previous trauma/infection or other condition
  3. Suspicion of other cause than triggeriinger/tendovaginitis
  4. Patient not able to follow instructions
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    proximal phalangeal level

    injection in the the tendon sheet over proximal phalanx of finger

    Procedure: Proximal phalangeal level

  • Active comparator
    volar MCP level

    injection above the A1 pulley volar to the MCP joint

    Drug: Volar to the MCP-joint

Interventions

  • ProcedureProximal phalangeal level

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

  • DrugVolar to the MCP-joint

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

05

What researchers measure

Primary outcomes

  1. Pain after injection

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

    Time frame: Four weeks

  2. Impairment of finger motion

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

    Time frame: Four weeks

  3. Triggering

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

    Time frame: Four weeks

Secondary outcomes

  1. Quick-DASH

    generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function

    Time frame: Four weeks

06

Study locations

1 site
  • Alingsås Lasarett/ District Hospital
    Alingsås, Sweden
07

Registry details

Key details

Study ID
NCT04568993
Lead sponsor
Sahlgrenska University Hospital
Responsible party
Joakim Stromberg (Senior consultant surgeon, MD, PhD, Sahlgrenska University Hospital) — Principal investigator
First posted
Sep 29, 2020
Start date
Oct 1, 2020
Primary completion
Nov 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Apr 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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