Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

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.

Study Overview

• Status: Unknown
• Conditions: Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Behavioral: Postural restriction; Behavioral: Normal daily activity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hatyai, Songkhla, Thailand, 90110
      • Recruiting
      • Yuvatiya Plodpoai
      • Contact: Yuvatiya Plodpoa, MD; Phone Number: 66015988403; Email: yuvatiya.plodpai@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: Normal daily activity; The patients did not follow any postural restrictions and were asked to live as normally as possible.	Behavioral: Normal daily activity; The patients did not follow any postural restrictions and were asked to live as normally as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Dix-Hallpike test	The Dix-Hallpike test results	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution time	Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike	24 weeks
Medication needed	Need of medication to treat vertigo (in this study, betahistine)	24 weeks
the Dizziness Handicap Inventory (DHI)		24 weeks
Recurrent rate		24 weeks

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Yuvatiya Plodpai, MD, Prince of Songkla University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 18, 2015

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Benign Paroxysmal Positional Vertigo, Postural Restriction
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: REC 57-0082-13-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No