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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Jordi Gol i Gurina Foundation
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network redIAPP G03/70
Red Española de Atención Primaria (REAP)
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier:
NCT01969513
First received: March 27, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Benign Positional Paroxysmal Vertigo
Procedure: PROCEDURE: EPLEY MANOEUVRE
Procedure: PROCEDURE: SHAM MANOEUVRE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • PERSISTENCE OF VERTIGO [ Time Frame: One week after recruitment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • BETAHISTINE TABLET COUNT [ Time Frame: One week after recruitment ] [ Designated as safety issue: No ]
    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

  • NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    Analyze if new episodes have occurred before the annual visit and calculate the elapsed time between the first visit and the new episode.

  • SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  • DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S) [ Time Frame: One week after recruitment ] [ Designated as safety issue: No ]

    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.


  • PATIENTS REPORTING PERSISTENCE OF VERTIGO [ Time Frame: One week after recruitment ] [ Designated as safety issue: No ]
    Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).

  • PATIENTS REPORTING PERSISTENCE OF VERTIGO [ Time Frame: One month after recruitment ] [ Designated as safety issue: No ]
    Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).

  • PATIENTS REPORTING PERSISTENCE OF VERTIGO [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]
    Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).

  • DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S) [ Time Frame: One month after recruitment ] [ Designated as safety issue: No ]

    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.


  • DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S) [ Time Frame: One year after recruitment ] [ Designated as safety issue: No ]

    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.


  • SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE [ Time Frame: One month after recruitment ] [ Designated as safety issue: No ]
    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  • SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE [ Time Frame: One week after recruitment ] [ Designated as safety issue: No ]
    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  • BETAHISTINE TABLET COUNT [ Time Frame: One month after recruitment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 104
Study Start Date: January 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INTERVENTION ARM
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
The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.
Other Name: Canalith repositioning manoeuvre
Sham Comparator: CONTROL GROUP
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
Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
Other Name: Simulated Epley manoeuvre

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969513

Contacts
Contact: José Luis Ballvé, MD 0034616026909 ballvejl@gmail.com

Locations
Spain
CAP Florida Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08905
Contact: Jose Luis Ballve Moreno, Ph    0034616026909    ballvejl@gmail.com   
Principal Investigator: José Luis Ballve Moreno, MD         
Sub-Investigator: Raquel Adroer Martori, MD         
Sub-Investigator: Ricard Carrillo Muñoz, MD         
Sub-Investigator: Yolanda Rando Matos, MD         
Sub-Investigator: Ivan Villar Balboa, MD         
Sub-Investigator: Jesus Almeda Ortega, Ph         
Sub-Investigator: Anabella María Hernández Sánchez, MD         
Sub-Investigator: Olga Bigas Aguilera, MD         
Sub-Investigator: Olga Lucia Arias Agudelo, MD         
Sub-Investigator: Alicia Capella Guillén, MD         
Sub-Investigator: Clara Johanna Buitrago Olaya, MD         
Sub-Investigator: Asha Vasudeva, MD         
Sub-Investigator: Xavier Monteverde Curto, MD         
Sub-Investigator: Estrella Rodero Perez, MD         
Sub-Investigator: Carles Rubio Ripolles, MD         
Sub-Investigator: Pamela Sepulveda Palacios, MD         
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Preventive Services and Health Promotion Research Network redIAPP G03/70
Red Española de Atención Primaria (REAP)
Investigators
Principal Investigator: José Luis Ballvé Institut Català de la Salut
  More Information

No publications provided

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT01969513     History of Changes
Other Study ID Numbers: 4R13/029-1, ID: 4R13/017
Study First Received: March 27, 2013
Last Updated: October 24, 2013
Health Authority: Spain: Ministry of Health

Keywords provided by Jordi Gol i Gurina Foundation:
Vestibular Diseases
Vertigo
Primary care
Epley maneuver

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on September 16, 2014