Back to resultsEfficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Postural restriction
Normal daily activity
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Benign Paroxysmal Positional Vertigo, Postural Restriction
Eligibility Criteria
Inclusion Criteria:
- Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
- A negative neurologic examination
Exclusion Criteria:
- Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
- Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
- Patients who used medications that affected the neurologic and otologic systems for less than 48 hours
Sites / Locations
- Yuvatiya PlodpoaiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Postural restriction
Normal daily activity
Arm Description
The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours.
The patients did not follow any postural restrictions and were asked to live as normally as possible.
Outcomes
Primary Outcome Measures
The Dix-Hallpike test
The Dix-Hallpike test results
Secondary Outcome Measures
Resolution time
Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike
Medication needed
Need of medication to treat vertigo (in this study, betahistine)
the Dizziness Handicap Inventory (DHI)
Recurrent rate
Full Information
NCT ID
NCT02475239
First Posted
June 10, 2015
Last Updated
June 16, 2015
Sponsor
Prince of Songkla University
1. Study Identification
Unique Protocol Identification Number
NCT02475239
Brief Title
Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Official Title
Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized controlled trial to compare the treatment efficacy of post-maneuver postural restriction with CRP alone in patients with posterior semicircular canal benign paroxysmal positional vertigo.
Detailed Description
Benign paroxysmal positional vertigo is the most common cause of vertigo. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.Some study designs were not randomized controlled trials. The present study offers an alternative way of postural restriction to maintain postural restriction as much as possible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Benign Paroxysmal Positional Vertigo, Postural Restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Postural restriction
Arm Type
Experimental
Arm Description
The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours.
Arm Title
Normal daily activity
Arm Type
Active Comparator
Arm Description
The patients did not follow any postural restrictions and were asked to live as normally as possible.
Intervention Type
Behavioral
Intervention Name(s)
Postural restriction
Intervention Description
The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours.
Intervention Type
Behavioral
Intervention Name(s)
Normal daily activity
Intervention Description
The patients did not follow any postural restrictions and were asked to live as normally as possible.
Primary Outcome Measure Information:
Title
The Dix-Hallpike test
Description
The Dix-Hallpike test results
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Resolution time
Description
Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike
Time Frame
24 weeks
Title
Medication needed
Description
Need of medication to treat vertigo (in this study, betahistine)
Time Frame
24 weeks
Title
the Dizziness Handicap Inventory (DHI)
Time Frame
24 weeks
Title
Recurrent rate
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
A negative neurologic examination
Exclusion Criteria:
Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
Patients who used medications that affected the neurologic and otologic systems for less than 48 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuvatiya Plodpai, MD
Phone
66815988403
Email
yuvatiya.plodpai@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuvatiya Plodpai, MD
Organizational Affiliation
Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuvatiya Plodpoai
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuvatiya Plodpoa, MD
Phone
66015988403
Email
yuvatiya.plodpai@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
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