Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

NCT02475239 | Unknown DMC

• 1 other identifier: REC 57-0082-13-1
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Benign Paroxysmal Positional Vertigo, Postural Restriction

Outcome Measures

Primary Outcomes (1)

• The Dix-Hallpike test

  The Dix-Hallpike test results

  2 weeks

Secondary Outcomes (4)

• Resolution time

  24 weeks

• Medication needed

  24 weeks

• the Dizziness Handicap Inventory (DHI)

  24 weeks

• Recurrent rate

  24 weeks

Study Arms (2)

Postural restriction

EXPERIMENTAL

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.

Behavioral: Postural restriction

Normal daily activity

ACTIVE COMPARATOR

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

Behavioral: Normal daily activity

Interventions

Postural restriction 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.

Postural restriction

Normal daily activity BEHAVIORAL

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

Normal daily activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
• A negative neurologic examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Yuvatiya Plodpoai

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuvatiya Plodpai, MD

  Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuvatiya Plodpai, MD

CONTACT

66815988403; yuvatiya.plodpai@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 18, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

TH (1)