Cargando…

Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo

BACKGROUND: Symptoms arising from vestibular system dysfunction are observed in 49–59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people wit...

Descripción completa

Detalles Bibliográficos
Autores principales: Marsden, J., Pavlou, M., Dennett, R., Gibbon, A., Knight-Lozano, R., Jeu, L., Flavell, C., Freeman, J., Bamiou, D. E., Harris, C., Hawton, A., Goodwin, E., Jones, B., Creanor, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694922/
https://www.ncbi.nlm.nih.gov/pubmed/33243182
http://dx.doi.org/10.1186/s12883-020-01983-y
_version_ 1783615082483154944
author Marsden, J.
Pavlou, M.
Dennett, R.
Gibbon, A.
Knight-Lozano, R.
Jeu, L.
Flavell, C.
Freeman, J.
Bamiou, D. E.
Harris, C.
Hawton, A.
Goodwin, E.
Jones, B.
Creanor, S.
author_facet Marsden, J.
Pavlou, M.
Dennett, R.
Gibbon, A.
Knight-Lozano, R.
Jeu, L.
Flavell, C.
Freeman, J.
Bamiou, D. E.
Harris, C.
Hawton, A.
Goodwin, E.
Jones, B.
Creanor, S.
author_sort Marsden, J.
collection PubMed
description BACKGROUND: Symptoms arising from vestibular system dysfunction are observed in 49–59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately. METHODS/ DESIGN: People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1–3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used. DISCUSSION: If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS. TRIAL REGISTRATION: ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-020-01983-y.
format Online
Article
Text
id pubmed-7694922
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-76949222020-11-30 Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo Marsden, J. Pavlou, M. Dennett, R. Gibbon, A. Knight-Lozano, R. Jeu, L. Flavell, C. Freeman, J. Bamiou, D. E. Harris, C. Hawton, A. Goodwin, E. Jones, B. Creanor, S. BMC Neurol Study Protocol BACKGROUND: Symptoms arising from vestibular system dysfunction are observed in 49–59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately. METHODS/ DESIGN: People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1–3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used. DISCUSSION: If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS. TRIAL REGISTRATION: ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12883-020-01983-y. BioMed Central 2020-11-27 /pmc/articles/PMC7694922/ /pubmed/33243182 http://dx.doi.org/10.1186/s12883-020-01983-y Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Marsden, J.
Pavlou, M.
Dennett, R.
Gibbon, A.
Knight-Lozano, R.
Jeu, L.
Flavell, C.
Freeman, J.
Bamiou, D. E.
Harris, C.
Hawton, A.
Goodwin, E.
Jones, B.
Creanor, S.
Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title_full Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title_fullStr Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title_full_unstemmed Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title_short Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
title_sort vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7694922/
https://www.ncbi.nlm.nih.gov/pubmed/33243182
http://dx.doi.org/10.1186/s12883-020-01983-y
work_keys_str_mv AT marsdenj vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT pavloum vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT dennettr vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT gibbona vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT knightlozanor vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT jeul vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT flavellc vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT freemanj vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT bamioude vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT harrisc vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT hawtona vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT goodwine vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT jonesb vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre
AT creanors vestibularrehabilitationinmultiplesclerosisstudyprotocolforarandomisedcontrolledtrialandcosteffectivenessanalysiscomparingcustomisedwithbookletbasedvestibularrehabilitationforvestibulopathyanda12monthobservationalcohortstudyofthesymptomreductionandrecurre