Benign Positional Paroxysmal Vertigo Clinical Trial
Official title:
Effectiveness of the Epley Manoeuvre Performed in Primary Care to Treat Posterior Canal Benign Paroxysmal Positional Vertigo
| Verified date | January 2017 |
| Source | Jordi Gol i Gurina Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | CAP Florida | L'Hospitalet de Llobregat | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Jordi Gol i Gurina Foundation | Fondo de Investigación Sanitaria (FIS) 2013 Instituto de Salud Carlos III, Preventive Services and Health Promotion Research Network, Red Española de Atención Primaria (REAP) |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | One week after recruitment | |
| Secondary | PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | One month after recruitment | |
| Secondary | PATIENTS REPORTING PERSISTENCE OF VERTIGO | Patients will inform if vertigo was present during the last week (Dichotomous variable: yes/no). | One year after recruitment | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |