A randomised controlled trial of the clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injections: The hip injection trial (HIT) protocol

Zoe Paskins, Gemma Hughes, Helen Myers, Emily Hughes, Susie Hennings, Andrea Cherrington, Amy Evans, Melanie Holden, Kay Stevenson, Ajit Menon, Kieran Bromley, Philip Roberts, Alison Hall, George Peat, Clare Jinks, Raymond Oppong, Martyn Lewis, Nadine E. Foster, Christian Mallen, Edward Roddy

Research output: Contribution to journalArticlepeer-review

3 Citations (Scopus)

Abstract

Background: Evidence on the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis is limited and conflicting. The primary objective of the Hip Injection Trial (HIT) is to compare pain intensity over 6 months, in people with hip OA between those receiving an ultrasound-guided intra-articular hip injection of corticosteroid with 1% lidocaine hydrochloride plus best current treatment with those receiving best current treatment alone. Secondary objectives are to determine specified comparative clinical and cost-effectiveness outcomes, and to explore, in a linked qualitative study, the lived experiences of patients with hip OA and experiences and impact of, ultrasound-guided intra-articular hip injection. Methods: The HIT trial is a pragmatic, three-parallel group, single-blind, superiority, randomised controlled trial in patients with painful hip OA with a linked qualitative study. The current protocol is described, in addition to details and rationale for amendments since trial registration. 204 patients with moderate-to-severe hip OA will be recruited. Participants are randomised on an equal basis (1:1:1 ratio) to one of three interventions: (1) best current treatment, (2) best current treatment plus ultrasound-guided intra-articular hip injection of corticosteroid (triamcinolone acetonide 40 mg) with 1% lidocaine hydrochloride, or (3) best current treatment plus an ultrasound-guided intra-articular hip injection of 1% lidocaine hydrochloride alone. The primary endpoint is patient-reported hip pain intensity across 2 weeks, 2 months, 4 months and 6 months post-randomisation. Recruitment is over 29 months with a 6-month follow-up period. To address the primary objective, the analysis will compare participants' 'average' follow-up pain NRS scores, based on a random effects linear repeated-measures model. Data on adverse events are collected and reported in accordance with national guidance and reviewed by external monitoring committees. Individual semi-structured interviews are being conducted with up to 30 trial participants across all three arms of the trial. Discussion: To ensure healthcare services improve outcomes for patients, we need to ensure there is a robust and appropriate evidence-base to support clinical decision making. The HIT trial will answer important questions regarding the clinical and cost-effectiveness of intra-articular corticosteroid injections. Trial registration: ISRCTN: 50550256, 28th July 2015.

Original languageEnglish
Article number218
JournalBMC Musculoskeletal Disorders
Volume19
Issue number1
DOIs
Publication statusPublished - 18 Jul 2018

Bibliographical note

Funding Information:
This study was funded by the National Institute for Health Research for Patient Benefit (PB PG 0213 30027). CDM is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands. CDM is also funded by the NIHR School for Primary Care Research and an NIHR Research Professorship in General Practice (NIHR-RP-2014-04-026). NEF, an NIHR Senior Investigator, was funded by an NIHR Research Professorship (NIHR-RP-2011-015).

Funding Information:
The HIT trial is conducted by Keele University Research Institute for Primary Care & Health Sciences and Keele Clinical Trials Unit and sponsored by Keele University (Sponsors office - Directorate of Research, Innovation and Engagement). CDM and CJ are part-funded by the National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care West Midlands. CDM is also funded by the NIHR School for Primary Care Research and a NIHR Research Professorship in General Practice (NIHR-RP-2014-04-026). NEF, an NIHR Senior Investigator, was funded by an NIHR Research Professorship (NIHR-RP-2011-015). KB is funded by NIHR Research Methods Fellowship funding (NIHR-RM-FI-2017-08-006) linked to NEF’s NIHR Senior Investigator award. KS was funded by a NIHR knowledge mobilisation fellowship. MAH was funded by the National Institute for Health Research (NIHR) School for Primary Care Research. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The authors thank Elaine Thomas for input into the original sample size calculation and statistical analysis plan, Sue Jowett for advice on health economics, Jennifer Liddle for input into the nested qualitative component, Liz Mason, Alicia Bratt, Jamie Garner, Zoe Mayson, Rebecca Whittle, Jo Smith, Helen Duffy and Emma Skinner who were involved in the trial design, drafting of the operational protocol and/or initiating the study set up through to first site opening. They also thank members of the Keele Research User group, patient representatives and members of the TSC and DMC who supported the design of the trial and who continue to work with the team.

Funding Information:
This study was funded by the National Institute for Health Research for Patient Benefit (PB PG 0213 30027). CDM is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands. CDM is also funded by the NIHR School for Primary Care Research and an NIHR Research Professorship in General Practice (NIHR-RP-2014-04-026). NEF, an NIHR Senior Investigator, was funded by an NIHR Research Professorship (NIHR-RP-2011-015). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The funder was not involved in the study design or the decision to submit the article for publication. The Haywood Rheumatology Research and Development Foundation have also contributed funding for the qualitative component.

Publisher Copyright:
© 2018 The Author(s).

ASJC Scopus subject areas

  • Rheumatology
  • Orthopedics and Sports Medicine

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