Clinical trial NCT00182273: Canalith Repositioning Procedure for BPPV in Primary Care
Official title: Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Benign paroxysmal positional vertigo
Canalith repositioning maneuver
Dizziness
Primary Care
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 ear nose and throat (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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Duration of cure, relapse rates
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Juan Munoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munoz JE, Miklea JT, Howard M, Springate R, Kaczorowski J. Canalith repositioning maneuver for benign paroxysmal positional vertigo: randomized controlled trial in family practice. Can Fam Physician. 2007 Jun;53(6):1049-53, 1048.