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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This study has been withdrawn prior to enrollment.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
History of Changes

September 16, 2009
September 11, 2011
September 2009
June 2010   (final data collection date for primary outcome measure)
postural stability [ Time Frame: 60 days post treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00978809 on ClinicalTrials.gov Archive Site
subjective vertigo [ Time Frame: 60 days post treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients
Epley Maneuver vs. Semont Maneuver for Benign Paroxysmal Positional Vertigo (BPPV): Evaluating Treatment Effectiveness by Postural Stability - a Double Blinded Randomized Controlled Trial.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Benign Paroxysmal Positional Vertigo
  • Other: Epley maneuver
    Other Name: canalith repositioning maneuver
  • Other: Semont maneuver
    Other Name: liberatory manoeuvre
  • Active Comparator: Semont
    BPPV patients treated by Semont maneuver by a physical therapist.
    Intervention: Other: Semont maneuver
  • No Intervention: control
    healthy volunteers.
  • Active Comparator: Epley maneuver
    BPPV patients treated with Epley maneuver by a physical therapist.
    Intervention: Other: Epley maneuver

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
30
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00978809
BPPV-2, 2009051
No
Hellmann Ory, Maccabi Health Services
Assuta Hospital Systems
Ben-Gurion University of the Negev
Study Chair: Itshak Melzer, Dr Ben-Gurion University of the Negev
Study Director: Moshe Puterman, Dr Soroka University Medical Center
Assuta Hospital Systems
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP