Clinical effectiveness of one ultrasound guided intra-articular corticosteroid and local anaesthetic injection in addition to advice and education for hip osteoarthritis (HIT trial): single blind, parallel group, three arm, randomised controlled trial

Abstract

Objectives: to compare the clinical effectiveness of best current treatment (BCT) plus single ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride [BCT+US-Triamcinolone-Lidocaine] with BCT alone [BCT] and, secondarily, compare clinical effectiveness of BCT+US-Triamcinolone-Lidocaine, with BCT combined with an USGI of 5ml 1% lidocaine [BCT+US-Lidocaine]. Design: Pragmatic, three-arm parallel-group, single-blind randomised controlled trial. Setting: 2 community musculoskeletal services in England Participants: Adults aged =40 years with hip OA and at least moderate pain were eligible. 199 participants (43% male, mean age 63 years), were randomly assigned - 67 to arm (1) and 66 each to arms (2) and (3). Average weighted follow-up rate across time-points was 93%. Interventions: (1) BCT, (2) BCT+US-Triamcinolone-Lidocaine, or (3) BCT+US-Lidocaine. In the USGI arms, participants were not told which injection they received (to ensure masking). Main outcome measures: The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months. Secondary outcomes included pain and physical function (Western Ontario and McMaster University Osteoarthritis Index, WOMAC), pain self-efficacy, participant’s global impression of change and general health (EQ-5D-5L). Results: Greater mean improvement in hip pain intensity over 6 months was seen with BCT+US-Triamcinolone-Lidocaine compared with BCT: mean difference -1.43 (95%CI -2.15, -0.72). Participants treated with BCT+US-Triamcinolone-Lidocaine compared with BCT had greater mean improvement in function (WOMAC-F -5.47; -9.41, -1.53) and pain self-efficacy (5.87; 2.30, 9.45) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT+US-Triamcinolone-Lidocaine compared with BCT+US-Lidocaine (-0.52; -1.21, 0.18). However, a statistically significant difference was seen in favour of BCT+US-Triamcinolone-Lidocaine in comparison with BCT+US-Lidocaine for a range of secondary outcome measures, over 6 months (e.g. pain self-efficacy, function, and work presenteeism). The presence of synovitis or effusion on ultrasound predicted response to BCT+US-Triamcinolone-Lidocaine (-1.7; -3.1, -0.3). One participant in the BCT+US-Triamcinolone-Lidocaine arm with a bio-prosthetic aortic valve died 4 months after the intervention from subacute bacterial endocarditis, deemed possibly related to the trial treatment. Conclusions: USGI of triamcinolone acetonide is an additional treatment option to add to best current care for people with hip OA. As in routine clinical practice, caution should be applied in patients with risk factors for, or signs of infection.