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NCT Number: NCT01969513

Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat 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.

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Key information

Conditions

Benign Positional Paroxysmal Vertigo Benign Paroxysmal Positional Vertigo Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAP Florida

L'Hospitalet de Llobregat, Barcelona, 08905, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PROCEDURE: EPLEY MANOEUVRE

Procedure

The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.

Other names: Canalith repositioning manoeuvre

PROCEDURE: SHAM MANOEUVRE

Procedure

Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.

Other names: Simulated Epley manoeuvre

Primary outcomes

  1. PERSISTENCE OF VERTIGO

    Time frame: One week after recruitment

    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 outcomes

  1. BETAHISTINE TABLET COUNT

    Time frame: One week after recruitment

    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

  2. NEW EPISODES OF BENIGN PAROXYSMAL POSITIONAL VERTIGO IN THE ANNUAL VISIT

    Time frame: One year after recruitment

    Analyze if new episodes have occurred before the annual visit and calculate the elapsed time between the first visit and the new episode.

  3. SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE

    Time frame: One year after recruitment

    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  4. DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)

    Time frame: One week after recruitment

    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.

  5. PATIENTS REPORTING PERSISTENCE OF VERTIGO

    Time frame: One week after recruitment

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

  6. PATIENTS REPORTING PERSISTENCE OF VERTIGO

    Time frame: One month after recruitment

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

  7. PATIENTS REPORTING PERSISTENCE OF VERTIGO

    Time frame: One year after recruitment

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

  8. DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)

    Time frame: One month after recruitment

    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.

  9. DIZZINESS HANDICAP INVENTORY SHORT FORM (DHI-S)

    Time frame: One year after recruitment

    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.

  10. SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE

    Time frame: One month after recruitment

    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  11. SEVERITY OF VERTIGO MEASURED ON A LIKERT SCALE

    Time frame: One week after recruitment

    Patients will be asked to rate the severity of the vertigo on a 10 point Likert scale: 0 = not experiencing, 10 = worst and unbearable.

  12. BETAHISTINE TABLET COUNT

    Time frame: One month after recruitment

    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.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Instituto de Salud Carlos III
  • Preventive Services and Health Promotion Research Network
  • Red Española de Atención Primaria (REAP)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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