Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Benign Paroxysmal Positional Vertigo

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo

Conditions
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Benign Positional Paroxysmal Vertigo

Intervention / Treatment
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* Procedure: PROCEDURE: EPLEY MANOEUVRE
* Procedure: PROCEDURE: SHAM MANOEUVRE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERVENTION ARM<br>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<br>* The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.<br>* Other names: Canalith repositioning manoeuvre;|
| Sham Comparator: CONTROL GROUP<br>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<br>* Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.<br>* Other names: Simulated Epley manoeuvre;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | One week after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | One week after recruitment | 
| PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | One week after recruitment | 
| PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | One month after recruitment | 
| PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | 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. | 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. | 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. | 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. | 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. | One month after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vestibular Diseases, Vertigo, Primary care, Epley maneuver