Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective r
- PDF / 924,106 Bytes
- 9 Pages / 595.276 x 790.866 pts Page_size
- 52 Downloads / 150 Views
STUDY PROTOCOL
Open Access
Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial Samuli Aspinen1*† , Panu H. Nordback1†, Turkka Anttila1, Susanna Stjernberg-Salmela1, Jorma Ryhänen1 and Jussi Kosola2
Abstract Background: Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain’s disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo. Methods: The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied. Discussion: We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger. Trial registration: ClinicalTrials.gov NCT04167098. Registered on November 18, 2019. Keywords: Clinical trial, Platelet-rich plasma, Trigger finger, Trigger thumb, Stenosing tenosynovitis
* Correspondence: [email protected] † Samuli Aspinen and Panu Nordback share joint authorship as first author. 1 Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260 Helsinki, Finland Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are
Data Loading...
