AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study

Roberto Eleopra,Araldo Causero,Carmine Tamborino,Christian Lettieri,Carmelo Lentino,Grazia Devigili,Andrea Santamato,Sara Rinaldo,Paolo Bortolotti

doi:10.3390/toxins10110448

Abstract

Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport®) (AboBoNT-A) injections versus placebo as a novel treatment option to improve hip range of motion, pain and quality of life. This prospective randomized double-blind multicenter study (EudraCT # 2012-004890-25) recruited 46 outpatients with hip OA who were randomized 2:1 to the Treatment Group (TG; 31 subjects), or the Placebo Group (PG; 15 subjects). The TG received 400 U of AboBoNT-A injected into the adductor muscles, and the PG received placebo solution. The primary endpoints were the difference in Harris Hip Score (HHS) and Visual Analogic Scale for pain (VAS) at Week 4 between groups (TG vs. PG). Secondary endpoints were the change from baseline in HHS, VAS pain, Medical Research Council scale for muscle strength (MRC) and Short Form scale (SF-36) scores. In TG at Week 4, the HHS and VAS score were significantly improved compared to PG, and pairwise assessments showed significant improvements in HSS and VAS pain at each time point compared to baseline for TG. No significant changes were observed in MRC and SF-36 over time, though SF-36 showed a positive trend. There were no significant differences from baseline in the PG. No adverse events were detected in either treatment group. AboBoNT-A injections in hip OA improve range of motion and pain without any significant side effects.

Highlights

Hip Osteoarthritis (OA) is a major cause of pain and disability in Western populations [1]. hip OA most frequently occurs in the elderly, many cases can occur before retirement, when hip OA can seriously impact a patient’s ability to work [1]
Before implantation of total hip arthroplasty (THA), hip OA was commonly approached by surgical detachment of the most important muscles of the hip joint contracted, achieving the purpose of interrupting, in an efficient and lasting manner, the vicious cycle induced by the combination of pain-contraction and contraction-pain
In our prospective randomized double-blind multicenter study, we aimed to confirm whether administration of aboBoNT-A versus placebo on hip range of motion, pain and quality of life have an efficacy in subjects with hip OA

Summary

Introduction

Hip Osteoarthritis (OA) is a major cause of pain and disability in Western populations [1]. Hip OA most frequently occurs in the elderly, many cases can occur before retirement, when hip OA can seriously impact a patient’s ability to work [1]. As longevity increases and raised retirement ages require people to work longer, the scale of this problem is expected to grow [2,3,4]. (2018) reveals that in Europe the incidence of hip OA is variable in the elderly, and higher in Italy (13.8%) in comparison to the overall Europe frequency (5.9%) [5]. All patients experience the same impairment with hip OA: Diminution of range of motion, pain and functional incapacity, as well as altered biomechanics of walking. Severe hip OA is often treated with surgery, the main surgical technique being total hip arthroplasty (THA) [6,7,8]

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