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

September 13, 2005
September 13, 2005
January 2002
Not Provided
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
Same as current
No Changes Posted
Duration of cure, relapse rates
Same as current
Not Provided
Not Provided
 
Canalith Repositioning Procedure for BPPV in Primary Care
Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Benign Paroxysmal Positional Vertigo
Procedure: Canalith repositioning maneuver (CRM)
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 2005
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182273
01-24
Not Provided
Not Provided
Hamilton Health Sciences Corporation
Not Provided
Principal Investigator: Juan Munoz, MD McMaster University
McMaster University
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP