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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04568993
Other study ID # The TriggerHappy Trial
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 1, 2024

Study information

Verified date January 2023
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Proximal phalangeal level
Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx
Drug:
Volar to the MCP-joint
Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint

Locations

Country Name City State
Sweden Alingsås Lasarett/ District Hospital Alingsås

Sponsors (1)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain after injection Visual analouge scale (VAS), range 0-10, where 0 indicates "no pain" and 10 "maximum pain" Four weeks
Primary Impairment of finger motion Visual analouge scale (VAS), range 0-10, where 0 indicates "no impairment" and 10 "maximum impairment" Four weeks
Primary 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 Quick-DASH generic handquestionaire, 11 items, 0 means normal hand function, 100 most impaired function Four weeks
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