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

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status

Withdrawn

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Epley maneuver

Semont maneuver

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring BPPV, postural stability, Epley, Semont

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Maccabi health services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Active Comparator

Arm Label

Semont

control

Epley maneuver

Arm Description

BPPV patients treated by Semont maneuver by a physical therapist.

healthy volunteers.

BPPV patients treated with Epley maneuver by a physical therapist.

Outcomes

Primary Outcome Measures

postural stability

Secondary Outcome Measures

subjective vertigo

Full Information

NCT ID

NCT00978809

First Posted

September 16, 2009

Last Updated

April 16, 2015

Sponsor

Assuta Hospital Systems

Collaborators

Ben-Gurion University of the Negev

1. Study Identification

Unique Protocol Identification Number

NCT00978809

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Withdrawn

Why Stopped

major difficulties recruiting patients

Study Start Date

September 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Assuta Hospital Systems

Collaborators

Ben-Gurion University of the Negev

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Paroxysmal Positional Vertigo

Keywords

BPPV, postural stability, Epley, Semont

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Semont

Arm Type

Active Comparator

Arm Description

BPPV patients treated by Semont maneuver by a physical therapist.

Arm Title

control

Arm Type

No Intervention

Arm Description

healthy volunteers.

Arm Title

Epley maneuver

Arm Type

Active Comparator

Arm Description

BPPV patients treated with Epley maneuver by a physical therapist.

Intervention Type

Other

Intervention Name(s)

Epley maneuver

Other Intervention Name(s)

canalith repositioning maneuver

Intervention Type

Other

Intervention Name(s)

Semont maneuver

Other Intervention Name(s)

liberatory manoeuvre

Primary Outcome Measure Information:

Title

postural stability

Time Frame

60 days post treatment

Secondary Outcome Measure Information:

Title

subjective vertigo

Time Frame

60 days post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Itshak Melzer, Dr

Organizational Affiliation

Ben-Gurion University of the Negev

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Moshe Puterman, Dr

Organizational Affiliation

Soroka University Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Maccabi health services

City

Beer Sheva

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

10821549

Citation

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. doi: 10.1016/s0196-0709(00)80045-9.

Results Reference

background

PubMed Identifier

9655200

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. doi: 10.1080/00016489850183340.

Results Reference

background

Learn more about this trial

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

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