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NCT00978809 Clinical Trial

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

Benign Paroxysmal Positional Vertigo Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00978809
Other study ID # BPPV-2
Secondary ID 2009051
Status Withdrawn
Phase N/A
First received September 16, 2009
Last updated April 16, 2015
Start date September 2009
Est. completion date June 2010

Study information
Verified date June 2011
Source Assuta Hospital Systems
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Epley maneuver

• Semont maneuver

Locations
Country Name City State
Israel Maccabi health services Beer Sheva

Sponsors (2)
Lead Sponsor Collaborator
Assuta Hospital Systems Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Blatt PJ, Georgakakis GA, Herdman SJ, Clendaniel RA, Tusa RJ. The effect of the canalith repositioning maneuver on resolving postural instability in patients with benign paroxysmal positional vertigo. Am J Otol. 2000 May;21(3):356-63. — View Citation

Di Girolamo S, Paludetti G, Briglia G, Cosenza A, Santarelli R, Di Nardo W. Postural control in benign paroxysmal positional vertigo before and after recovery. Acta Otolaryngol. 1998 Jun;118(3):289-93. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary postural stability 60 days post treatment No
Secondary subjective vertigo 60 days post treatment No
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