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Canalith Repositioning Procedure for BPPV in Primary Care

This study has been completed.

Sponsored by: Hamilton Health Sciences
Information provided by: McMaster University
ClinicalTrials.gov Identifier: NCT00182273
  Purpose

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.


Condition Intervention Phase
Benign Paroxysmal Positional Vertigo
Procedure: Canalith repositioning maneuver (CRM)
Phase III

MedlinePlus related topics:   Dizziness and Vertigo   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial

Further study details as provided by McMaster University:

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

Secondary Outcome Measures:
  • Duration of cure, relapse rates

Estimated Enrollment:   56
Study Start Date:   January 2002
Estimated Study Completion Date:   June 2005

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182273

Locations
Canada, Ontario
McMaster University    
      Hamilton, Ontario, Canada, L8N 3Z5

Sponsors and Collaborators
Hamilton Health Sciences

Investigators
Principal Investigator:     Juan Munoz, MD     McMaster University    
  More Information


Publications indexed to this study:

Study ID Numbers:   01-24
First Received:   September 13, 2005
Last Updated:   September 13, 2005
ClinicalTrials.gov Identifier:   NCT00182273
Health Authority:   Canada: Health Canada

Keywords provided by McMaster University:
Benign paroxysmal positional vertigo  
Canalith repositioning maneuver  
Dizziness  
Primary Care  

Study placed in the following topic categories:
Signs and Symptoms
Benign paroxysmal positional vertigo
Otorhinolaryngologic Diseases
Dizziness
Neurologic Manifestations
Vestibular Diseases
Ear Diseases
Vertigo

Additional relevant MeSH terms:
Nervous System Diseases
Labyrinth Diseases

ClinicalTrials.gov processed this record on October 29, 2008




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