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Open Access Study protocol

Effectiveness of the Epley’s maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial

José Luis Ballve Moreno1*, Ricard Carrillo Muñoz2, Iván Villar Balboa2, Yolanda Rando Matos1, Olga Lucia Arias Agudelo1, Asha Vasudeva1, Olga Bigas Aguilera2, Jesús Almeda Ortega3, Alicia Capella Guillén1, Clara Johanna Buitrago Olaya1, Xavier Monteverde Curto1, Estrella Rodero Perez1, Carles Rubio Ripollès1, Pamela Catalina Sepulveda Palacios2, Noemí Moreno Farres1, Anabella María Hernández Sánchez4, Carlos Martin Cantera5 and Rafael Azagra Ledesma6

Author Affiliations

1 Centre d’Atenció Primària (CAP) Florida Nord, Institut Català de la Salut, Hospitalet de Llobregat, de Llobregat, Spain

2 Centre d’Atenció Primària (CAP) Florida Sud, Institut Català de la Salut, Hospitalet de Llobregat, de Llobregat, Spain

3 Técnico de Salud de Soporte a la Investigación. Unitat de Suport a la Recerca. Direcció d’Atenció Primaria de Costa de Ponent. Gerencia Territorial Metropolitana Sud, Institut Català de la Salut (ICS), Barcelona, Spain

4 Hospital General de Hospitalet, Hospitalet de Llobregat, de Llobregat, Spain

5 Departament de Medicina, Equip d’Atenció Primària Barcelona, Universitat Autònoma de Barcelona, Passeig Sant Joan, Barcelona, Spain

6 Equip d’Atenció Primària Badia del Valles. Servei d’Atenció Primària Vallés Occidental. USR IDIAP Jordi Gol. Direcció d’Atenció Primària Metropolitana Nord, Institut Català de la Salut, Universitat Autònoma de Barcelona, Barcelona, Spain

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Trials 2014, 15:179  doi:10.1186/1745-6215-15-179

Published: 21 May 2014

Abstract

Background

Vertigo is a common medical condition with a broad spectrum of diagnoses which requires an integrated approach to patients through a structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV), which should be confirmed by a positive D-H positional test and treated with repositioning maneuvers. The objective of this study is to evaluate the effectiveness of Epley’s maneuver performed by general practitioners (GPs) in the treatment of BPPV.

Methods/Design

This study is a randomized clinical trial conducted in the primary care setting. The study’s scope will include two urban primary care centers which provide care for approximately 49,400 patients. All patients attending these two primary care centers, who are newly diagnosed with benign paroxysmal positional vertigo, will be invited to participate in the study and will be randomly assigned either to the treatment group (Epley’s maneuver) or to the control group (a sham maneuver). Both groups will receive betahistine. Outcome variables will be: response to the D-H test, patients’ report on presence or absence of vertigo during the previous week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert-type scale in the previous week, total score on the Dizziness Handicap Inventory (DHI) and quantity of betahistine taken.

We will use descriptive statistics of all variables collected. Groups will be compared using the intent-to-treat approach and either parametric or nonparametric tests, depending on the nature and distribution of the variables. Chi-square test or Fisher’s exact test will be conducted to compare categorical measures and Student’s t-test or Mann–Whitney U-test will be used for intergroup comparison variables.

Discussion

Positive results from our study will highlight that treatment of benign paroxysmal positional vertigo can be performed by trained general practitioners (GPs) and, therefore, its widespread practice may contribute to improve the quality of life of BPPV patients.

Trial registration

ClinicalTrials.gov Identifier: NCT01969513.

Keywords:
Primary care; Canalith repositioning procedure; Benign paroxysmal positional vertigo; Randomized clinical trial; Betahistine