An interventional study of PROCEDURE: EPLEY MANOEUVRE and PROCEDURE: SHAM MANOEUVRE in Benign Positional Paroxysmal Vertigo, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Treatment
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.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's enrollment of 153 is above the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA
Patients 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.
Procedure: PROCEDURE: EPLEY MANOEUVRE
Patients 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.
Procedure: PROCEDURE: SHAM MANOEUVRE
The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.
Also known as: Canalith repositioning manoeuvre
Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
Also known as: Simulated Epley manoeuvre
PERSISTENCE OF VERTIGO
Evaluate if the Dix Hallpike manoeuvre produces dizziness or nystagmus to the right or left or both sides. If they are present at both sides the manoeuvre will be considered positive for the side where the symptoms are intense.
Time frame: One week after recruitment
BETAHISTINE TABLET COUNT
All patients will be prescribed betahistine 8mg three times a day until they no longer have symptoms. We will analyze whether patients' self-report of the sum of betahistine tablets taken are lower in intervention group in comparison to control group
Time frame: One week after recruitment
NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT
Analyze if new episodes have occurred before the annual visit and calculate the elapsed time between the first visit and the new episode.
Time frame: One year after recruitment
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.
Time frame: One year after recruitment
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
The questionnaire used is an adapted version of the original DHI into Spanish by López- Escamez. It was translated and back translated by two interpreters with clinical experience and both translations were discussed in a consensus meeting with one of the researchers yielding to an adapted version. The internal consistency coefficient, Cronbach alpha, was 0.8014. This 10 item self-assessment inventory will evaluate the self-perceived handicapping effects imposed by dizziness.
Time frame: One week after recruitment
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time frame: One week after recruitment
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time frame: One month after recruitment
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time frame: One year after recruitment
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
The questionnaire used is an adapted version of the original DHI into Spanish by López- Escamez. It was translated and back translated by two interpreters with clinical experience and both translations were discussed in a consensus meeting with one of the researchers yielding to an adapted version. The internal consistency coefficient, Cronbach alpha, was 0.8014. This 10 item self-assessment inventory will evaluate the self-perceived handicapping effects imposed by dizziness.
Time frame: One month after recruitment
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
The questionnaire used is an adapted version of the original DHI into Spanish by López- Escamez. It was translated and back translated by two interpreters with clinical experience and both translations were discussed in a consensus meeting with one of the researchers yielding to an adapted version. The internal consistency coefficient, Cronbach alpha, was 0.8014. This 10 item self-assessment inventory will evaluate the self-perceived handicapping effects imposed by dizziness.
Time frame: One year after recruitment
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.
Time frame: One month after recruitment
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.
Time frame: One week after recruitment
BETAHISTINE TABLET COUNT
All patients will be prescribed betahistine 8mg three times a day until they no longer have symptoms. We will analyze whether patients' self-report of the sum of betahistine tablets taken are lower in intervention group in comparison to control group.
Time frame: One month after recruitment
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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