Rehne L Hansen1, Jeppe Lange. 1. Centre for Planned Surgery, Regional Hospital Silkeborg, 8600 Silkeborg, Denmark. rehnhans@rm.dk
Abstract
INTRODUCTION: Trigger fingers have been reported in the literature for over a century; yet, the lack of trials comparing open surgery to corticosteroid injection is pronounced. At the initiation of the present study in 2010, no randomized controlled trials could be found comparing open surgery to corticosteroid injection. In the present randomized controlled trial, we plan to compare the efficacy of a single ultrasound-guided corticosteroid injection with conventional open surgery in terms of ability to correct the trigger finger. MATERIAL AND METHODS: The study is performed as an open-label single-centre, randomised controlled trial with a one-year follow-up. Patients are randomly assigned to either ultrasound-guided corticosteroid injection (n = 83) or to open surgical release of A1-pulley (n = 83). Follow-up is conducted at 12 weeks and one year after treatment. The affected finger will be assessed using a trigger finger score. Furthermore, any treatment complications, absence from work or sport and use of related medical services or additional treatment are also recorded. DISCUSSION: The present study will be the first to compare treatment of trigger finger by conventional open surgery with ultrasound-guided corticosteroid injection in a randomized controlled trial. The results will contribute to evidence-based recommendations for the treatment of trigger finger patients. FUNDING: not relevant. TRIAL REGISTRATION: Danish Data Protection Agency (1-16-02-119-11). The Central Denmark Region Committees on Biomedical Research Ethics (M-20110157). Clinicaltrials.gov: NCT 01486420.
RCT Entities:
INTRODUCTION: Trigger fingers have been reported in the literature for over a century; yet, the lack of trials comparing open surgery to corticosteroid injection is pronounced. At the initiation of the present study in 2010, no randomized controlled trials could be found comparing open surgery to corticosteroid injection. In the present randomized controlled trial, we plan to compare the efficacy of a single ultrasound-guided corticosteroid injection with conventional open surgery in terms of ability to correct the trigger finger. MATERIAL AND METHODS: The study is performed as an open-label single-centre, randomised controlled trial with a one-year follow-up. Patients are randomly assigned to either ultrasound-guided corticosteroid injection (n = 83) or to open surgical release of A1-pulley (n = 83). Follow-up is conducted at 12 weeks and one year after treatment. The affected finger will be assessed using a trigger finger score. Furthermore, any treatment complications, absence from work or sport and use of related medical services or additional treatment are also recorded. DISCUSSION: The present study will be the first to compare treatment of trigger finger by conventional open surgery with ultrasound-guided corticosteroid injection in a randomized controlled trial. The results will contribute to evidence-based recommendations for the treatment of trigger finger patients. FUNDING: not relevant. TRIAL REGISTRATION: Danish Data Protection Agency (1-16-02-119-11). The Central Denmark Region Committees on Biomedical Research Ethics (M-20110157). Clinicaltrials.gov: NCT 01486420.
Authors: Oliver Kloeters; Dietmar J O Ulrich; Gijs Bloemsma; Claire I A van Houdt Journal: Arch Orthop Trauma Surg Date: 2016-02-29 Impact factor: 3.067