Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

NCT ID: NCT02475239

Last Updated: 2015-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-06-30

Brief Summary

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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

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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.

Conditions

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Benign Paroxysmal Positional Vertigo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Postural restriction

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.

Group Type EXPERIMENTAL

Postural restriction

Intervention Type BEHAVIORAL

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.

Normal daily activity

The patients did not follow any postural restrictions and were asked to live as normally as possible.

Group Type ACTIVE_COMPARATOR

Normal daily activity

Intervention Type BEHAVIORAL

The patients did not follow any postural restrictions and were asked to live as normally as possible.

Interventions

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Postural restriction

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

Normal daily activity

The patients did not follow any postural restrictions and were asked to live as normally as possible.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Yuvatiya Plodpai

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuvatiya Plodpai, MD

Role: PRINCIPAL_INVESTIGATOR

Prince of Songkla University

Locations

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Yuvatiya Plodpoai

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Yuvatiya Plodpai, MD

Role: CONTACT

66815988403

Facility Contacts

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Yuvatiya Plodpoa, MD

Role: primary

66015988403

Other Identifiers

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REC 57-0082-13-1

Identifier Type: -

Identifier Source: org_study_id

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