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Clinical Trials/NCT04568993
NCT04568993Active, not recruitingNot Applicable

Patient-reported Outcome After Corticoid Injection for Triggerfinger- a Randomized Controlled Study Between Two Injection Procedures and Between Corticoid Injection and Percutaneous Release

Sahlgrenska University Hospital1 site in 1 country100 target enrollmentStarted: October 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Impairment of finger motion

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

proximal phalangeal level

Experimental

injection in the the tendon sheet over proximal phalanx of finger

Intervention: Proximal phalangeal level (Procedure)

volar MCP level

Active Comparator

injection above the A1 pulley volar to the MCP joint

Intervention: Volar to the MCP-joint (Drug)

Outcomes

Primary Outcomes

Impairment of finger motion

Time Frame: Four weeks

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

Triggering

Time Frame: Four weeks

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

Pain after injection

Time Frame: Four weeks

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

Secondary Outcomes

  • Quick-DASH(Four weeks)

Investigators

Sponsor
Sahlgrenska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joakim Stromberg

Senior consultant surgeon, MD, PhD

Sahlgrenska University Hospital

Study Sites (1)

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