Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients

This study has been withdrawn prior to enrollment.
(major difficulties recruiting patients)
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by:
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT00978809
First received: September 16, 2009
Last updated: September 11, 2011
Last verified: June 2011
  Purpose

The propose of this study is to compare two methods of physical treatment for benign paroxysmal positional vertigo, by evaluating treatment effects on postural stability.

The trail design is a double blinded randomized controlled trail, with each patient going through three evaluations: before treatment, 1 week after treatment and 60 days after treatment.


Condition Intervention
Benign Paroxysmal Positional Vertigo
Other: Epley maneuver
Other: Semont maneuver

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • postural stability [ Time Frame: 60 days post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective vertigo [ Time Frame: 60 days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2009
Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Semont
BPPV patients treated by Semont maneuver by a physical therapist.
Other: Semont maneuver
Other Name: liberatory manoeuvre
No Intervention: control
healthy volunteers.
Active Comparator: Epley maneuver
BPPV patients treated with Epley maneuver by a physical therapist.
Other: Epley maneuver
Other Name: canalith repositioning maneuver

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • medical referral for treating "vertigo"
  • subject has short episodes of rotatory vertigo (up to 1 minute)
  • subject has positive Hallpike-Dix test with typical nystagmus
  • repeated Hallpike-dix test will show fatigability

Exclusion Criteria:

  • Hallpike-Dix test produces vertigo without nystagmus
  • subject has BPPV of the horizontal or anterior semi-circular canal
  • subject has other known vestibular or neurologic condition
  • subject has nystagmus of a different type
  • subject has a cervical spine problem which prevents the utilization of Epley or Semont maneuvers
  • subject is unable to stand for 1 minute
  • subject gets pharmacologic treatment for vertigo while doing the postural stability evaluation
  • subject is under 18 years old or a pregnant female or cannot obtain informed concent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978809

Locations
Israel
Maccabi health services
Beer Sheva, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Ben-Gurion University of the Negev
Investigators
Study Chair: Itshak Melzer, Dr Ben-Gurion University of the Negev
Study Director: Moshe Puterman, Dr Soroka University Medical Center
  More Information

Publications:
Responsible Party: Hellmann Ory, Maccabi Health Services
ClinicalTrials.gov Identifier: NCT00978809     History of Changes
Other Study ID Numbers: BPPV-2, 2009051
Study First Received: September 16, 2009
Last Updated: September 11, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Assuta Hospital Systems:
BPPV
postural stability
Epley
Semont

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

ClinicalTrials.gov processed this record on April 17, 2014