Canalith Repositioning Procedure for BPPV in Primary Care - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^†

January 2002

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Duration of cure, relapse rates

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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 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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Benign Paroxysmal Positional Vertigo

Intervention ^†

Procedure: Canalith repositioning maneuver (CRM)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

June 2005

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00182273

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hamilton Health Sciences

Collaborators ^††

Investigators ^†

Principal Investigator:

Juan Munoz, MD

McMaster University

Information Provided By

McMaster University

Verification Date

June 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.