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

被引:7
作者
Eleopra, Roberto [1 ]
Rinaldo, Sara [1 ]
Lettieri, Christian [2 ]
Santamato, Andrea [3 ]
Bortolotti, Paolo [4 ]
Lentino, Carmelo [5 ]
Tamborino, Carmine [6 ]
Causero, Araldo [7 ]
Devigili, Grazia [1 ]
机构
[1] Fdn IRCCS Ist Neurol Carlo Besta, Neurol Unit 1, I-20133 Milan, Italy
[2] S Maria della Misericordia Univ Hosp, Neurol Unit, I-33010 Udine, Italy
[3] Riuniti Hosp, Phys Med & Rehabil Unit, I-71122 Foggia, Italy
[4] Villa Rosa Rehabil Hosp APSS TN, Neurol Unit, I-38057 Trento, Italy
[5] Santa Corona Hosp, Phys Med & Rehabil Unit, Local Hlth Agcy Savonese 2, I-17027 Pietra Ligure, SV, Italy
[6] DellAngelo Hosp, Neurol Unit, I-30174 Venice, Italy
[7] S Maria della Misericordia Univ Hosp Udine, Inst Orthoped Surg, I-33010 Udine, Italy
关键词
botulinum toxin; hip; osteoarthritis; rehabilitation; pain; BOTULINUM-TOXIN; ARTHROPLASTY; KNEE; RECOMMENDATIONS; PATIENT;
D O I
10.3390/toxins10110448
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport((R))) (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.
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页数:10
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