Canalith Repositioning Procedure for BPPV in Primary Care
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | September 13, 2005 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Duration of cure, relapse rates | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Canalith Repositioning Procedure for BPPV in Primary Care | ||||
| Official Title ICMJE | Treatment of Benign Paroxysmal Positional Vertigo With the Canalith Repositioning Procedure in Family Practice: A Randomized Controlled Trial | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Benign Paroxysmal Positional Vertigo | ||||
| Intervention ICMJE | Procedure: Canalith repositioning maneuver (CRM) | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 56 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00182273 | ||||
| Other Study ID Numbers ICMJE | 01-24 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Hamilton Health Sciences Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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