Benign Positional Paroxysmal Vertigo Clinical Trial
Official title:
Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo
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.
DESIGN:
Randomized clinical trial conducted by general practitioners (GP) who received a two hour
training to perform the manoeuvres under the supervision of an otorhinolaryngologist.
Patients will be reevaluated 1 week, 1 month and 1 year after the first visit by a different
GP from the first visit to accomplish blinding of study participants and personnel.
MAIN OBJECTIVE:
The aim of this study is to determine whether the improvement is greater in intervention
group than in control group in terms of Dix-Hallpike manoeuvre turning negative, subjective
perception of vertigo and quality of life, and less amount of betahistine taken.
The main objective is the response of treatment in the second visit (1 week after the first
visit), although new assessments will be carried out at day 30 and one year after the first
visit.
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