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

NCT00978809 | Withdrawn

• 2 other identifiers: BPPV-22009051
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

BPPV; postural stability; Epley; Semont

Outcome Measures

Primary Outcomes (1)

• postural stability

  60 days post treatment

Secondary Outcomes (1)

• subjective vertigo

  60 days post treatment

Study Arms (3)

Semont

ACTIVE COMPARATOR

BPPV patients treated by Semont maneuver by a physical therapist.

Other: Semont maneuver

control

NO INTERVENTION

healthy volunteers.

Epley maneuver

ACTIVE COMPARATOR

BPPV patients treated with Epley maneuver by a physical therapist.

Other: Epley maneuver

Interventions

Epley maneuver OTHER

Also known as: canalith repositioning maneuver

Epley maneuver

Semont maneuver OTHER

Also known as: liberatory manoeuvre

Semont

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assuta Hospital Systems: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Maccabi health services

Beersheba, Israel

Location

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

  PMID: 10821549 BACKGROUND

• 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.

  PMID: 9655200 BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Itshak Melzer, Dr

  Ben-Gurion University of the Negev

  STUDY CHAIR

• Moshe Puterman, Dr

  Soroka University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 17, 2015

Record last verified: 2011-06

Locations

IL (1)