AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study
Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport<sup>®</sup>) (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 s...
| Main Authors: | , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
MDPI AG
2018-10-01
|
| Series: | Toxins |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-6651/10/11/448 |
| _version_ | 1828357955597107200 |
|---|---|
| author | Roberto Eleopra Sara Rinaldo Christian Lettieri Andrea Santamato Paolo Bortolotti Carmelo Lentino Carmine Tamborino Araldo Causero Grazia Devigili |
| author_facet | Roberto Eleopra Sara Rinaldo Christian Lettieri Andrea Santamato Paolo Bortolotti Carmelo Lentino Carmine Tamborino Araldo Causero Grazia Devigili |
| author_sort | Roberto Eleopra |
| collection | DOAJ |
| description | Hip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport<sup>®</sup>) (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. |
| first_indexed | 2024-04-14T03:22:59Z |
| format | Article |
| id | doaj.art-d866342350a34d64b47ab2d10dccd683 |
| institution | Directory Open Access Journal |
| issn | 2072-6651 |
| language | English |
| last_indexed | 2024-04-14T03:22:59Z |
| publishDate | 2018-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Toxins |
| spelling | doaj.art-d866342350a34d64b47ab2d10dccd6832022-12-22T02:15:15ZengMDPI AGToxins2072-66512018-10-01101144810.3390/toxins10110448toxins10110448AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter StudyRoberto Eleopra0Sara Rinaldo1Christian Lettieri2Andrea Santamato3Paolo Bortolotti4Carmelo Lentino5Carmine Tamborino6Araldo Causero7Grazia Devigili8Neurological Unit 1, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, 20133 Milan, ItalyNeurological Unit 1, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, 20133 Milan, ItalyNeurological Unit, “S.Maria della Misericordia” University Hospital, 33010 Udine, ItalyPhysical Medicine and Rehabilitation Unit, “Riuniti” Hospital, 71122 Foggia, ItalyNeurological Unit, “Villa Rosa” Rehabilitation Hospital (APSS TN), 38057 Trento, ItalyPhysical Medicine and Rehabilitation Unit, “Santa Corona” Hospital, (Local Health Agency 2 Savonese), 17027 Pietra Ligure (SV), ItalyNeurological Unit, “Dell’Angelo” Hospital, 30174 Venice, ItalyInstitute of Orthopedic Surgery, “S.Maria della Misericordia” University Hospital of Udine, 33010 Udine, ItalyNeurological Unit 1, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, 20133 Milan, ItalyHip Osteoarthritis (OA) causes pain and disability. Here we evaluate abobotulinumtoxinA (Dysport<sup>®</sup>) (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.https://www.mdpi.com/2072-6651/10/11/448botulinum toxinhiposteoarthritisrehabilitationpain |
| spellingShingle | Roberto Eleopra Sara Rinaldo Christian Lettieri Andrea Santamato Paolo Bortolotti Carmelo Lentino Carmine Tamborino Araldo Causero Grazia Devigili AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study Toxins botulinum toxin hip osteoarthritis rehabilitation pain |
| title | AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study |
| title_full | AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study |
| title_fullStr | AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study |
| title_full_unstemmed | AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study |
| title_short | AbobotulinumtoxinA: A New Therapy for Hip Osteoarthritis. A Prospective Randomized Double-Blind Multicenter Study |
| title_sort | abobotulinumtoxina a new therapy for hip osteoarthritis a prospective randomized double blind multicenter study |
| topic | botulinum toxin hip osteoarthritis rehabilitation pain |
| url | https://www.mdpi.com/2072-6651/10/11/448 |
| work_keys_str_mv | AT robertoeleopra abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT sararinaldo abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT christianlettieri abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT andreasantamato abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT paolobortolotti abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT carmelolentino abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT carminetamborino abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT araldocausero abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy AT graziadevigili abobotulinumtoxinaanewtherapyforhiposteoarthritisaprospectiverandomizeddoubleblindmulticenterstudy |