Canalith Repositioning Procedure for BPPV in Primary Care

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182273
• Other study ID #: 01-24
• Status: Completed
• Phase: Phase 3
• Start date: January 2002
• Est. completion date: June 2005

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 ear nose and throat (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

Procedure:
• Canalith repositioning maneuver (CRM)

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of cure, relapse rates