Canalith Repositioning Procedure for BPPV in Primary Care

Study Overview
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Brief Summary
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The purpose of this study is to see whether family doctors can treat benign paroxysmal positional vertigo (BPPV), or dizziness, using a procedure in the office. The study is looking at whether the treatment procedure cures the dizziness in more patients compared to patients that receive a sham or placebo procedure.

Detailed Description
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Many patients consult their family physicians because of dizziness. This is a disabling condition with serious consequences, especially in older people, as it may lead to falls and consequent fractures. One of the most common causes of dizziness is the so-called Benign Paroxysmal Positional Vertigo (BPPV). Patients with BPPV typically have severe vertigo provoked by a change in head position. Benign Paroxysmal Positional Vertigo can now be accurately diagnosed, and distinguished form other dizziness producing conditions, in the physician's office and without any sophisticated diagnostics tools. Furthermore, it can be treated in the office setting by specific head positioning maneuvers (Canalith Repositioning Procedure) that are easy to learn and perform. The Canalith Repositioning Procedure is currently almost exclusively performed in specialized settings by ENT and Internal Medicine specialists. Its efficacy has been demonstrated in these settings. However, to-date no studies have been conducted in the primary care settings about the use and efficacy of the procedure, where the condition is first seen and assessed. This is a randomized controlled trial to determine whether the procedure performed by family doctors cures dizziness.

Official Title
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Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial

Conditions
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Benign Paroxysmal Positional Vertigo

Intervention / Treatment
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* Procedure: Canalith repositioning maneuver (CRM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed BPPV by positive Dix-Hallpike test Exclusion Criteria: · Positive results of the Dix-Hallpike maneuver in both right and left head-hanging position; Evidence of ongoing central nervous system disease (e.g., transient ischemic attack); Otitis media; Osteosclerosis; Inability to tolerate a diagnostic Dix-Hallpike head-hanging maneuver; Severe degenerative disc disease of cervical spine; Severe and uncontrolled angina or hypertension

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Canalith repositioning maneuver (CRM)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported resolution (affirmative response to question: Do you feel that the dizziness has completely resolved?) of vertigo and/or a negative result of the Dix-Hallpike maneuver |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of cure, relapse rates |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign paroxysmal positional vertigo, Canalith repositioning maneuver, Dizziness, Primary Care