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Canalith Repositioning Procedure for BPPV in Primary Care

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00182273
First received: September 13, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by McMaster University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

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

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on May 23, 2013