NCT00182273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

First QC Date

September 13, 2005

Last Update Submit

March 12, 2024

Conditions

Keywords

Benign paroxysmal positional vertigoCanalith repositioning maneuverDizzinessPrimary Care

Outcome Measures

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

Interventions

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed BPPV by positive Dix-Hallpike test

You may not qualify if:

  • · 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Benign Paroxysmal Positional VertigoDizziness

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Officials

  • Juan Munoz, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

January 1, 2002

Study Completion

June 1, 2005

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations