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OpenTrials
Completed

NCT Number: NCT00182273

Canalith Repositioning Procedure for BPPV in Primary Care

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.

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Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Canalith repositioning maneuver (CRM)

Procedure

Primary outcomes

  1. 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 outcomes

  1. Duration of cure, relapse rates

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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