search
Back to results

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

Primary Purpose

Benign Positional Paroxysmal Vertigo

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PROCEDURE: EPLEY MANOEUVRE
PROCEDURE: SHAM MANOEUVRE
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Positional Paroxysmal Vertigo focused on measuring Vestibular Diseases, Vertigo, Primary care, Epley maneuver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CAP Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

INTERVENTION ARM

CONTROL GROUP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
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.
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.
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.
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.
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.

Full Information

First Posted
March 27, 2013
Last Updated
January 23, 2017
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network, Red Española de Atención Primaria (REAP), Instituto de Salud Carlos III
search

1. Study Identification

Unique Protocol Identification Number
NCT01969513
Brief Title
Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Benign Paroxysmal Positional Vertigo
Official Title
Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Preventive Services and Health Promotion Research Network, Red Española de Atención Primaria (REAP), Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Positional Paroxysmal Vertigo
Keywords
Vestibular Diseases, Vertigo, Primary care, Epley maneuver

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION ARM
Arm Type
Experimental
Arm Description
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.
Arm Title
CONTROL GROUP
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
PROCEDURE: EPLEY MANOEUVRE
Other Intervention Name(s)
Canalith repositioning manoeuvre
Intervention Description
The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.
Intervention Type
Procedure
Intervention Name(s)
PROCEDURE: SHAM MANOEUVRE
Other Intervention Name(s)
Simulated Epley manoeuvre
Intervention Description
Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
Primary Outcome Measure Information:
Title
PERSISTENCE OF VERTIGO
Description
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
Secondary Outcome Measure Information:
Title
BETAHISTINE TABLET COUNT
Description
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
Title
NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT
Description
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
Title
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Description
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
Title
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
Description
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
Title
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Description
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time Frame
One week after recruitment
Title
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Description
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time Frame
One month after recruitment
Title
PATIENTS REPORTING PERSISTENCE OF VERTIGO
Description
Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no).
Time Frame
One year after recruitment
Title
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
Description
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
Title
DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)
Description
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
Title
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Description
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
Title
SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE
Description
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
Title
BETAHISTINE TABLET COUNT
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Ballvé
Organizational Affiliation
Institut Català de la Salut
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAP Florida
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08905
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31722671
Citation
Carrillo Munoz R, Ballve Moreno JL, Villar Balboa I, Rando Matos Y, Cunillera Puertolas O, Almeda Ortega J, Rodero Perez E, Monteverde Curto X, Rubio Ripolles C, Moreno Farres N, Matos Mendez A, Gomez Nova JC, Bardina Santos M, Villarreal Minano JJ, Pacheco Erazo DL, Hernandez Sanchez AM; Grupo de estudio del vertigo en atencion primaria Florida. Disability perceived by primary care patients with posterior canal benign paroxysmal positional vertigo. BMC Fam Pract. 2019 Nov 13;20(1):156. doi: 10.1186/s12875-019-1035-3.
Results Reference
derived
PubMed Identifier
24886338
Citation
Ballve Moreno JL, Carrillo Munoz R, Villar Balboa I, Rando Matos Y, Arias Agudelo OL, Vasudeva A, Bigas Aguilera O, Almeda Ortega J, Capella Guillen A, Buitrago Olaya CJ, Monteverde Curto X, Rodero Perez E, Rubio Ripolles C, Sepulveda Palacios PC, Moreno Farres N, Hernandez Sanchez AM, Martin Cantera C, Azagra Ledesma R. Effectiveness of the Epley's maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial. Trials. 2014 May 21;15:179. doi: 10.1186/1745-6215-15-179.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs