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Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

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ClinicalTrials.gov Identifier: NCT02475239
Recruitment Status : Unknown
Verified June 2015 by Yuvatiya Plodpai, Prince of Songkla University.
Recruitment status was:  Recruiting
First Posted : June 18, 2015
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
Yuvatiya Plodpai, Prince of Songkla University

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.

Condition or disease Intervention/treatment Phase
Benign Paroxysmal Positional Vertigo Behavioral: Postural restriction Behavioral: Normal daily activity Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo
Study Start Date : December 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. The Dix-Hallpike test [ Time Frame: 2 weeks ]
    The Dix-Hallpike test results


Secondary Outcome Measures :
  1. Resolution time [ Time Frame: 24 weeks ]
    Time interval until the patient report recurrent vertigo confirmed by positive Dix-Hallpike

  2. Medication needed [ Time Frame: 24 weeks ]
    Need of medication to treat vertigo (in this study, betahistine)

  3. the Dizziness Handicap Inventory (DHI) [ Time Frame: 24 weeks ]
  4. Recurrent rate [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475239


Contacts
Contact: Yuvatiya Plodpai, MD 66815988403 yuvatiya.plodpai@gmail.com

Locations
Thailand
Yuvatiya Plodpoai Recruiting
Hatyai, Songkhla, Thailand, 90110
Contact: Yuvatiya Plodpoa, MD    66015988403    yuvatiya.plodpai@gmail.com   
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Yuvatiya Plodpai, MD Prince of Songkla University

Responsible Party: Yuvatiya Plodpai, Doctor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT02475239     History of Changes
Other Study ID Numbers: REC 57-0082-13-1
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Yuvatiya Plodpai, Prince of Songkla University:
Benign Paroxysmal Positional Vertigo, Postural Restriction

Additional relevant MeSH terms:
Vertigo
Dizziness
Benign Paroxysmal Positional Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders