Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02475239
• Other study ID #: REC 57-0082-13-1
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2015
• Last updated: June 16, 2015
• Start date: December 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2015
• Source: Prince of Songkla University
• Contact: Yuvatiya Plodpai, MD
• Phone: 66815988403
• Email: yuvatiya.plodpai[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

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

Locations

Country	Name	City	State
Thailand	Yuvatiya Plodpoai	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Dix-Hallpike test	The Dix-Hallpike test results	2 weeks	No
Secondary	Resolution time	Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike	24 weeks	No
Secondary	Medication needed	Need of medication to treat vertigo (in this study, betahistine)	24 weeks	No
Secondary	the Dizziness Handicap Inventory (DHI)		24 weeks	No
Secondary	Recurrent rate		24 weeks	No