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Epley Manoeuvre for Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo in People with Multiple Sclerosis: Protocol of a Randomised Controlled Trial

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Epley Manoeuvre for Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo in People with Multiple Sclerosis: Protocol of a Randomised Controlled Trial Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-046510 on 18 March 2021. Downloaded from Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial Cristina García- Muñoz ,1 María- Dolores Cortés- Vega ,1 Juan Carlos Hernández- Rodríguez ,2 Rocio Palomo- Carrión,3 Rocío Martín- Valero ,4 María Jesús Casuso- Holgado 1 To cite: García- Muñoz C, ABSTRACT Strengths and limitations of this study Cortés- Vega M- D, Hernández- Introduction Vestibular disorders in multiple sclerosis (MS) Rodríguez JC, et al. Epley could have central or peripheral origin. Although the central ► This randomised controlled trial will be the first to manoeuvre for posterior aetiology is the most expected in MS, peripheral damage is semicircular canal benign address knowledge gap on the effectiveness of the also significant in this disease. The most prevalent effect of paroxysmal positional vertigo in Epley manoeuvre in a multiple sclerosis population. vestibular peripheral damage is benign paroxysmal positional people with multiple sclerosis: ► Double- blind and concealed allocation will reduce vertigo (BPPV). Impairments of the posterior semicircular protocol of a randomised the possibility of bias. controlled trial. canals represent 60%–90% of cases of BPPV. The standard BMJ Open ► Videonystagmography goggles will enable the pri- gold treatment for this syndrome is the Epley manoeuvre (EM), 2021;11:e046510. doi:10.1136/ mary outcome of the research to be measured more bmjopen-2020-046510 the effectiveness of which has been poorly studied in patients objectively. with MS. Only one retrospective research study and a case ► Prepublication history and ► The Epley manoeuvre is an easy and quick vestib- study have reported encouraging results for EM with regard additional material for this ular treatment that results in significant changes in to resolution of posterior semicircular canal BPPV. The aim of paper are available online. To benign paroxysmal positional vertigo in a short pe- this future randomised controlled trial (RCT) is to assess the view these files, please visit riod of time. the journal online (http:// dx. doi. effectiveness of EM for BPPV in participants with MS compared ► Due to possible changes in drug treatment and man- http://bmjopen.bmj.com/ org/ 10. 1136/ bmjopen- 2020- with a sham manoeuvre. ifestation of multiple sclerosis flares, it is difficult to 046510). Methods and analysis The current protocol describes an RCT perform a long- term evaluation of the sample. with two- arm, parallel- group design. Randomisation, concealed Received 02 November 2020 allocation and double-blinding will be conducted to reduce Revised 01 March 2021 possible bias. Participants and evaluators will be blinded to Accepted 02 March 2021 group allocation. At least 80 participants who meet all eligibility the most recurrent symptoms in MS, with criteria will be recruited. Participants will have the EM or sham a direct repercussion on activities of daily manoeuvre performed within the experimental or control group, living.3 4 respectively. The primary outcome of the study is changes in This symptomatology could be 5 6 on October 2, 2021 by guest. Protected copyright. the Dix Hallpike test. The secondary outcome will be changes caused by a vestibular system affection. In in self- perceived scales: Dizziness Handicap Inventory and MS, vestibular affection could have peripheral Vestibular Disorders Activities of Daily Living Scale. The sample or central origin.7 8 Central vestibulopathy will be evaluated at baseline, immediately after the intervention impairments can appear in neuroanatomical and 48 hours postintervention. locations such as in the eighth cranial nerve, Ethics and dissemination The study was approved by the vestibular nuclei, oculomotor tracts, medial Andalusian Review Board and Ethics Committee of Virgen longitudinal fasciculus and cerebellum.9 On Macarena- Virgen del Rocio Hospitals (ID 0107- N-20, 23 July © Author(s) (or their 2020). The results of the research will be disseminated by the the other hand, peripheral vestibulopathy employer(s)) 2021. Re- use investigators to peer- reviewed journals. is due to damages in the vestibular system, permitted under CC BY- NC. No 5 Trial registration number NCT04578262. highlighting the semicircular canals. Within commercial re- use. See rights and permissions. Published by these canals, the most common affection is BMJ. located in the altered information recorded 10–12 For numbered affiliations see INTRODUCTION by the posterior semicircular canal. In end of article. Multiple sclerosis (MS) is a chronic autoim- MS, although central demyelination is the most expected, vestibular peripheral aeti- Correspondence to mune disease characterised by demyelin- 1 2 9 13 Dr María- Dolores Cortés- Vega; ation, gliosis and neural loss. Disturbances ology is also quite common. In the study by mdcortes@ us. es in postural control and dizziness are among Zeigelboim et al,13 it was determined that 86% García- Muñoz C, et al. BMJ Open 2021;11:e046510. doi:10.1136/bmjopen-2020-046510 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-046510 on 18 March 2021. Downloaded from of cases of MS with vestibular problems had a peripheral METHODS AND ANALYSIS origin. Study design The main symptom observed when a vestibulopathy This protocol describes a two- arm, parallel-group design exists is vertigo, defined as an instability associated with and a double- blind, randomised clinical trial. A prospec- a rotation sensation of oneself with respect to the envi- tive study with randomised and concealed allocation will ronment. The problem is exacerbated by fast head move- be performed to prevent possible bias. Participants and ments and positional changes.14–16 Furthermore, the most evaluators will be blinded to group allocation. The RCT common cause of vertigo without another associated will have three evaluations of the sample which will be neurological sign is benign paroxysmal positional vertigo carried out at baseline, immediately after the interven- (BPPV).9 14 BPPV is a syndrome defined as episodes of tion and 48 hours later. The study design is described in vertigo that last less than 60 s.17–19 The magnitude of figure 1. BPPV in patients with MS has been shown in the research This protocol meets the Standard Protocol Items: of Frohman et al,9 where 52% of the sample presented Recommendations for Interventional Trials.32 The RCT BPPV. Affection of the posterior semicircular canals is will be developed following instructions from the Consol- also apparent in 60%–90% of BPPV cases.20 21 idated Standards of Reporting Trials.33 This study has The Dix Hallpike manoeuvre is considered the gold been registered at ClinicalTrials. gov. standard in identifying posterior semicircular canal BPPV.22 23 If confirmed in this trial, the treatment of Study setting choice will be the Epley manoeuvre (EM),22 24–26 which The trial will be conducted at the Physical Therapy Depart- has been reported effective in 80%–100% of patients with ment of the University of Sevilla (Spain). The Vithas Nisa posterior canal BPPV.27 Hospital will be the main healthcare institution involved Due to the central or peripheral origin of vertigo in in this research. Inclusion of other healthcare centres in the MS population, an exhaustive neuro- otological eval- the area is expected. uation must be carried out for an accurate diagnosis.7 28 Participants and recruitment Nystagmus is one of the key symptoms to make a differen- Recruitment of participants is expected to start in tial diagnosis. In vertigo of peripheral origin, nystagmus February 2021 and is estimated to be completed in June has a counterclockwise or clockwise movement sum to 2022. It will be carried out in the healthcare institutions of the horizontal direction.18 29 30 In vertigo of central origin, the participants. To recruit the study sample, the research there are characteristic atypical movements with only one team will first contact the Multiple Sclerosis Unit of Seville direction. Additionally, peripheral nystagmus is fatigable Vithas Nisa Hospital (Spain). Next, patients with MS who and fades with an inhibiting effect of ocular fixation.6 9 28 meet the eligibility criteria will be phoned and given an Finally, in patients with MS, if the vertigo is of peripheral explanation regarding the development and conditions origin, a specific vestibular rehabilitation programme can http://bmjopen.bmj.com/ of the RCT. After providing oral and written information, be indicated.7 9 This rehabilitation is based on canalith the subjects will be free to decide if they wish to partici- repositioning procedures aimed at removing the otolith pate. After the invitation, participants who desire to be debris inside the particular canal.13 22 27 part of the study will sign the written informed consent Notwithstanding the efficacy of EM for treatment of (see online supplemental material 1 for the informed BPPV, this has been poorly studied in the MS population consent form). within the scientific literature. Only two previous research studies have investigated this manoeuvre as an interven- Inclusion criteria tion for BPPV in patients with MS. The first was a retro- ► on October 2, 2021 by guest. Protected copyright. 28 Adults of both genders aged 18–65 years old. spective study conducted by Frohman et al who reported ► Clinically diagnosed of any MS subtype (relapsing- that 100% of participants with MS with BPPV successfully remitting, primary progressive and secondary recovered after receiving EM. The second was a case study 31 progressive). conducted by Yoosefinejad and Siravani of a participant ► Expanded Disability Status Scale score ranging from with relapsing- remitting MS who suffered from BPPV. 1 to 5 points. Interventions applied in this research were the Epley and ► Diagnosed with posterior semicircular canal BPPV by Semont manoeuvres and the BPPV remitted postinter- an otolaryngologist and a physical therapist expert in vention. In addition, the participant with MS declared vestibular rehabilitation. more independence in activities of daily living.
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