Benign Positional Paroxysmal Vertigo | Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Benign Paroxysmal Positional Vertigo
Benign Positional Paroxysmal Vertigo research study
What is the primary objective of this study?
Vertigo is a common medical issue with a broad expectrum of diagnoses that requires a global approach to patients through structured clinical interview and physical examination. The main cause of vertigo in primary care is benign paroxysmal positional vertigo (BPPV) that is confirmed by a positive Dix-Hallpike positional test and treated with repositioning manoeuvres. Objective: To evaluate the effectiveness of Epley's manoeuvre performed by general practitioners (GPs) in the treatment of BPPV. Design: randomized clinical trial conducted in primary care. Scope: Two urban centres serving about 50,000 patients. Patients: All patients with newly diagnosed BPPV will be offered to participate in the study and will be randomly assigned to the treatment group (Epley manoeuvre) or control group (sham manoeuvre) and both groups will receive betahistine. Outcome variables will be: response to the Dix Hallpike test, patients will inform if vertigo was present during the last week (dichotomous variable: yes/no), intensity of vertigo symptoms on a Likert scale in the past week, score of Vertigo Handicap Inventory and quantity of betahistine taken. Statistical analysis: 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 exact Fisher test will be used to compare qualitative measures and Student's t test o Mann Whitney U test will be used for between-group comparison of variables. Positive results from our study will highlight that treatment of BPPV can be performed by trained GPs and its widespread practice can greatly improve the quality of life of these patients.
Who is eligible to participate?
INCLUSION CRITERIA - Patients aged 18 years and older who attend our primary care centre, with suspected diagnosis of BPPV, and present vertigo or nystagmus with DH manoeuvre. All other causes of vertigo will be ruled out. - Written informed consent will be obtained from all subjects of both intervention group and control group prior to its inclusion in the study. EXCLUSION CRITERIA - Previous or current diagnoses of labyrinth's diseases such as Meniere's disease, labyrinthitis or vestibular neuronitis. - Contraindications to canalith repositioning procedures: cervical spinal stenosis, severe kyphoscoliosis, limited cervical mobility, Down syndrome, advanced rheumatoid arthritis, cervical radiculopathies, Paget's disease, morbid obesity, ankylosing spondylitis, severe lumbar dysfunction and spinal cord injuries. - Pregnancy or breastfeeding. - Contraindications of betahistine. - Refusal of patients to participate in the study.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Benign Positional Paroxysmal Vertigo
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:PROCEDURE: EPLEY MANOEUVREThe procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.
Procedure:PROCEDURE: SHAM MANOEUVREPlacebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
INTERVENTION ARMPatients meeting the inclusion criteria will be randomly assigned to the experimental group. They will receive Epley's manoeuvre plus betahistine 8mg three times a day until they no longer have symptoms. The Epley's manoeuvre will be performed only on the first visit.
CONTROL GROUPPatients meeting the inclusion criteria will be randomly assigned to the control group. These patients will receive sham manoeuvre (simulated Epley manoeuvre) plus betahistine 8mg three times a day until they no longer have symptoms. Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
Start Date: November 2012
Completed Date: January 2015
Primary Outcome: PERSISTENCE OF VERTIGO
Secondary Outcome: BETAHISTINE TABLET COUNT
Study sponsors, principal investigator, and references
Principal Investigator: José Luis Ballvé
Lead Sponsor: Jordi Gol i Gurina Foundation
Collaborator: Preventive Services and Health Promotion Research Network