Epley manoeuvre for posterior semicircular canal benign paroxysmal positional vertigo in people with multiple sclerosis: protocol of a randomised controlled trial

BMJ Open. 2021 Mar 18;11(3):e046510. doi: 10.1136/bmjopen-2020-046510.

Abstract

Introduction: Vestibular disorders in multiple sclerosis (MS) could have central or peripheral origin. Although the central aetiology is the most expected in MS, peripheral damage is also significant in this disease. The most prevalent effect of vestibular peripheral damage is benign paroxysmal positional vertigo (BPPV). Impairments of the posterior semicircular canals represent 60%-90% of cases of BPPV. The standard gold treatment for this syndrome is the Epley manoeuvre (EM), the effectiveness of which has been poorly studied in patients with MS. Only one retrospective research study and a case study have reported encouraging results for EM with regard to resolution of posterior semicircular canal BPPV. The aim of this future randomised controlled trial (RCT) is to assess the effectiveness of EM for BPPV in participants with MS compared with a sham manoeuvre.

Methods and analysis: The current protocol describes an RCT with two-arm, parallel-group design. Randomisation, concealed allocation and double-blinding will be conducted to reduce possible bias. Participants and evaluators will be blinded to group allocation. At least 80 participants who meet all eligibility criteria will be recruited. Participants will have the EM or sham manoeuvre performed within the experimental or control group, respectively. The primary outcome of the study is changes in the Dix Hallpike test. The secondary outcome will be changes in self-perceived scales: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale. The sample will be evaluated at baseline, immediately after the intervention and 48 hours postintervention.

Ethics and dissemination: The study was approved by the Andalusian Review Board and Ethics Committee of Virgen Macarena-Virgen del Rocio Hospitals (ID 0107-N-20, 23 July 2020). The results of the research will be disseminated by the investigators to peer-reviewed journals.

Trial registration number: NCT04578262.

Keywords: neurology; otolaryngology; rehabilitation medicine.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Benign Paroxysmal Positional Vertigo / therapy
  • Dizziness
  • Humans
  • Multiple Sclerosis* / complications
  • Randomized Controlled Trials as Topic
  • Semicircular Canals
  • Vestibular Diseases*

Associated data

  • ClinicalTrials.gov/NCT04578262