Canalith Repositioning Procedure for BPPV in Primary Care
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Canalith repositioning maneuver (CRM)
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Benign paroxysmal positional vertigo, Canalith repositioning maneuver, Dizziness, Primary Care
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
Sites / Locations
- McMaster University
Outcomes
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
Full Information
NCT ID
NCT00182273
First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00182273
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Benign paroxysmal positional vertigo, Canalith repositioning maneuver, Dizziness, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Canalith repositioning maneuver (CRM)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Duration of cure, relapse rates
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Munoz, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17872784
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.
Results Reference
derived
Learn more about this trial
Canalith Repositioning Procedure for BPPV in Primary Care
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