The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray).
<h4>Background</h4>Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).<h4>Objectives</h4>To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabixim...
Main Authors: | , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Public Library of Science (PLoS)
2019-01-01
|
Series: | PLoS ONE |
Online Access: | https://doi.org/10.1371/journal.pone.0219670 |
id |
doaj-3fa879e346d44273a945eac9d4351567 |
---|---|
record_format |
Article |
spelling |
doaj-3fa879e346d44273a945eac9d43515672021-03-04T10:27:04ZengPublic Library of Science (PLoS)PLoS ONE1932-62032019-01-01147e021967010.1371/journal.pone.0219670The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray).Alessandro Enrico GrimaldiLaura De GiglioShalom HaggiagAssunta BiancoAntonio CorteseSebastiano Giuseppe CrisafulliFabrizia MonteleoneGerola MarfiaLuca ProsperiniSimonetta GalganiMassimiliano MirabellaDiego CentonzeCarlo PozzilliLetizia Castelli<h4>Background</h4>Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).<h4>Objectives</h4>To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.<h4>Methods</h4>This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.<h4>Results</h4>A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).<h4>Conclusions</h4>Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.https://doi.org/10.1371/journal.pone.0219670 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Alessandro Enrico Grimaldi Laura De Giglio Shalom Haggiag Assunta Bianco Antonio Cortese Sebastiano Giuseppe Crisafulli Fabrizia Monteleone Gerola Marfia Luca Prosperini Simonetta Galgani Massimiliano Mirabella Diego Centonze Carlo Pozzilli Letizia Castelli |
spellingShingle |
Alessandro Enrico Grimaldi Laura De Giglio Shalom Haggiag Assunta Bianco Antonio Cortese Sebastiano Giuseppe Crisafulli Fabrizia Monteleone Gerola Marfia Luca Prosperini Simonetta Galgani Massimiliano Mirabella Diego Centonze Carlo Pozzilli Letizia Castelli The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). PLoS ONE |
author_facet |
Alessandro Enrico Grimaldi Laura De Giglio Shalom Haggiag Assunta Bianco Antonio Cortese Sebastiano Giuseppe Crisafulli Fabrizia Monteleone Gerola Marfia Luca Prosperini Simonetta Galgani Massimiliano Mirabella Diego Centonze Carlo Pozzilli Letizia Castelli |
author_sort |
Alessandro Enrico Grimaldi |
title |
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). |
title_short |
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). |
title_full |
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). |
title_fullStr |
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). |
title_full_unstemmed |
The influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (THC:CBD oromucosal spray). |
title_sort |
influence of physiotherapy intervention on patients with multiple sclerosis-related spasticity treated with nabiximols (thc:cbd oromucosal spray). |
publisher |
Public Library of Science (PLoS) |
series |
PLoS ONE |
issn |
1932-6203 |
publishDate |
2019-01-01 |
description |
<h4>Background</h4>Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).<h4>Objectives</h4>To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.<h4>Methods</h4>This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.<h4>Results</h4>A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).<h4>Conclusions</h4>Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment. |
url |
https://doi.org/10.1371/journal.pone.0219670 |
work_keys_str_mv |
AT alessandroenricogrimaldi theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT lauradegiglio theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT shalomhaggiag theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT assuntabianco theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT antoniocortese theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT sebastianogiuseppecrisafulli theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT fabriziamonteleone theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT gerolamarfia theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT lucaprosperini theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT simonettagalgani theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT massimilianomirabella theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT diegocentonze theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT carlopozzilli theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT letiziacastelli theinfluenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT alessandroenricogrimaldi influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT lauradegiglio influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT shalomhaggiag influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT assuntabianco influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT antoniocortese influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT sebastianogiuseppecrisafulli influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT fabriziamonteleone influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT gerolamarfia influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT lucaprosperini influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT simonettagalgani influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT massimilianomirabella influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT diegocentonze influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT carlopozzilli influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray AT letiziacastelli influenceofphysiotherapyinterventiononpatientswithmultiplesclerosisrelatedspasticitytreatedwithnabiximolsthccbdoromucosalspray |
_version_ |
1714805938599231488 |