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

Objective: To compare the clinical effectiveness of adding a single ultrasound guided intra-articular hip injection of corticosteroid and local anaesthetic to advice and education in adults with hip osteoarthritis.

Design: Pragmatic, three arm, parallel group, single blind, randomised controlled trial.

Setting: Two community musculoskeletal services in England.

Participants: 199 adults aged ≥40 years with hip osteoarthritis and at least moderate pain: 67 were randomly assigned to receive advice and education (best current treatment (BCT)), 66 to BCT plus ultrasound guided injection of triamcinolone and lidocaine, and 66 to BCT plus ultrasound guided injection of lidocaine.

Interventions: BCT alone, BCT plus ultrasound guided intra-articular hip injection of 40 mg triamcinolone acetonide and 4 mL 1% lidocaine hydrochloride, or BCT plus ultrasound guided intra-articular hip injection of 5 mL 1% lidocaine. Participants in the ultrasound guided arms were masked to the injection they received.

Main outcome measures: The primary outcome was self-reported current intensity of hip pain (0-10 Numerical Rating Scale) over six months. Outcomes were self-reported at two weeks and at two, four, and six months.

Results: Mean age of the study sample was 62.8 years (standard deviation 10.0) and 113 (57%) were women. Average weighted follow-up rate across time points was 93%. Greater mean improvement in hip pain intensity over six months was reported with BCT plus ultrasound-triamcinolone-lidocaine compared with BCT: mean difference -1.43 (95% confidence interval -2.15 to -0.72), P<0.001; standardised mean difference -0.55 (-0.82 to -0.27). No difference in hip pain intensity over six months was reported between BCT plus ultrasound-triamcinolone-lidocaine compared with BCT plus ultrasound-lidocaine (-0.52 (-1.21 to 0.18)). The presence of ultrasound confirmed synovitis or effusion was associated with a significant interaction effect favouring BCT plus ultrasound-triamcinolone-lidocaine (-1.70 (-3.10 to -0.30)). One participant in the BCT plus ultrasound-triamcinolone-lidocaine group with a bioprosthetic aortic valve died from subacute bacterial endocarditis four months after the intervention, deemed possibly related to the trial treatment.

Conclusions: Ultrasound guided intra-articular hip injection of triamcinolone is a treatment option to add to BCT for people with hip osteoarthritis.

Trial registration: EudraCT 2014-003412-37; ISRCTN50550256.

Fig 1

Trial flow chart. BCT=best current treatment. ITT=intention to treat. US=ultrasound. *Numbers do not tally to total because multiple reasons may have been recorded. †Protocol violations related to treatment were noted for eight participants: three for BCT, four for BCT-ultrasound-lidocaine, and one for BCT-ultrasound-triamcinolone-lidocaine (these were excluded from per protocol sensitivity analysis). Mean pain score immediately before withdrawal was 3.4. ‡Follow-up data available on at least one occasion. Of 741 follow-up responses, eight (1%) were missing primary outcome data: one for BCT, five for BCT-ultrasound-triamcinolone-lidocaine, and two for BCT-ultrasound-lidocaine.

Fig 2

Summary of pain Numerical Rating Scale (primary outcome measure) by treatment group. BCT=best current treatment; US=ultrasound. An interactive version of this graphic is available at https://public.flourish.studio/visualisation/9137869/