The SToICAL trial: study protocol for the soft tissue injection of corticosteroid and local anaesthetic trial\u2014a single site, non-inferiority randomised control trial evaluating pain after soft tissue corticosteroid injections with and without local anaesthetic

Abstract

BackgroundCorticosteroid injections are used in the treatment of hand and wrist conditions. The co-administration of a local anaesthetic and corticosteroid aims to reduce pain after the injection, although no studies have directly compared this with using corticosteroid alone. The aim is to determine whether pain experienced during the 24 h after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection.MethodsA single-site, patient- and assessor-blinded, non-inferiority randomised control trial recording pain visual analogue scale (VAS) scores in patients with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome, treated with a 1-ml triamcinolone (40 mg/1 ml) injection co-administered with or without 1 ml of 1% lidocaine. The primary aim is to investigate a difference in pain VAS scores at 1 h after the injection using a mean change score.A 95% power calculation was made using a minimally clinical important difference of 20 mm as the clinically admissible margin of non-inferiority and an assumed standard deviation of 25 mm, from previous studies. Including a 20% fall out rate, 100 patients are required.DiscussionPatients with a clinical diagnosis of trigger finger, de Quervains and carpal tunnel syndrome, are over the age 18 years old and who are able to give written informed consent will be included. Patients will be excluded if they have had previous surgery or corticosteroid injection for the condition being treated at the site considered for injection.Patients will be electronically randomised and injections delivered during their clinic appointment. Pain is assessed using a 100-mm VAS score taken, before and at the time of injection and at 5 min, 1 h, 2 h, 3 h and 24 h after the injection. The secondary outcomes are to determine a difference in pain VAS score at the time of injection and during the 24 h after.Trial registrationThis study is registered on the IRAS (259336) on November 11, 2019, and EudraCT database on October 31, 2019 (2019-003742-32). REC/HRA approval was given in January 2020, and Clinical Trial Authorisation from the MHRA was given in December 2019. The study is registered on ClinicalTrials.gov (NCT04253457) on February 5, 2020.