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

Toxins

Araldo Causero¹  Grazia Devigili²  Roberto Eleopra²  Sara Rinaldo²  Carmine Tamborino³  Christian Lettieri⁴  Paolo Bortolotti⁵  Andrea Santamato⁶  Carmelo Lentino⁷ 

[1] Institute of Orthopedic Surgery, “S.Maria della Misericordia” University Hospital of Udine, 33010 Udine, Italy;Neurological Unit 1, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, 20133 Milan, Italy;Neurological Unit, “Dell’Angelo” Hospital, 30174 Venice, Italy;Neurological Unit, “S.Maria della Misericordia” University Hospital, 33010 Udine, Italy;Neurological Unit, “Villa Rosa” Rehabilitation Hospital (APSS TN), 38057 Trento, Italy;Physical Medicine and Rehabilitation Unit, “Riuniti” Hospital, 71122 Foggia, Italy;Physical Medicine and Rehabilitation Unit, “Santa Corona” Hospital, (Local Health Agency 2 Savonese), 17027 Pietra Ligure (SV), Italy;

关键词: botulinum toxin;    hip;    osteoarthritis;    rehabilitation;    pain;   

DOI  :  10.3390/toxins10110448

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown