Canalith Repositioning Procedure for BPPV in Primary Care

Phase 3

Completed

• Conditions: Benign Paroxysmal Positional Vertigo

• Registration Number: NCT00182273
• Lead Sponsor: McMaster University

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 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.

Study Timeline

• Study Start: 2002-01
• Study Completion: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of cure, relapse rates

Trial Locations

Locations (1)

McMaster University; 🇨🇦 Hamilton, Ontario, Canada