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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02615314
Other study ID # AnadoluMC
Secondary ID
Status Completed
Phase N/A
First received November 14, 2015
Last updated November 25, 2015
Start date January 2015
Est. completion date July 2015

Study information

Verified date November 2015
Source Anadolu Medical Center
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical Trial Summary

The aim of this study is to analyze the clinical aspects of patients with BPPV associated with migraine. It is our purpose to clarify weather migraine is a risk factor for BPPV if the clinical aspect and the therapeutic outcome is different.


Description:

Two hundred and sixty-three patients with BPPV were enrolled in this retrospective study. All patients' charts were reviewed by independent observer. The type of BPPV and associated problems were noted. Patients with migraine were investigated in terms of age, gender, symptoms, affected side and the cure rate. Their data were compared with those having no migraine. Mean values and standard deviations (± SD) were calculated. One way ANOVA test was used for the analysis. Significance was set at p < 0.005.


Recruitment information / eligibility

Status Completed
Enrollment 232
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 84 Years
Eligibility Inclusion Criteria:

- Patients who had history of head-induced positional and brief vertigo and who have been confirmed by VNG were included

Exclusion Criteria:

- Patients with balance problem other than BPPV,

- Patients receiving any medication prior to therapeutic maneuver were excluded

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Intervention

Procedure:
Particle re-positioning maneuver
Patients with posterior canal BPPV (PC-BPPV) were treated with Epley maneuver. Patients with superior canal (SC-BPPV) were treated with Li or reverse Epley maneuver. Patients with lateral canal (LC) apogeotropic or geotropic nystagmus were treated with Barbeque, Semont's or Gufoni maneuvers. If geotropic or ageotropic type nystagmus is equal intensity on both sides. The involved side was determined according to the patient sense of disturbance or lying down positioning test. If the patient has involvement of both sides according to Dix-Hallpike maneuver. Therapeutic maneuver was applied to the more severe side. All patients were re-evaluated at maximum 7 days.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Anadolu Medical Center

References & Publications (4)

Ishiyama A, Jacobson KM, Baloh RW. Migraine and benign positional vertigo. Ann Otol Rhinol Laryngol. 2000 Apr;109(4):377-80. — View Citation

Uneri A. Migraine and benign paroxysmal positional vertigo: an outcome study of 476 patients. Ear Nose Throat J. 2004 Dec;83(12):814-5. — View Citation

von Brevern M, Radtke A, Lezius F, Feldmann M, Ziese T, Lempert T, Neuhauser H. Epidemiology of benign paroxysmal positional vertigo: a population based study. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):710-5. Epub 2006 Nov 29. — View Citation

Yetiser S, Ince D. Demographic analysis of benign paroxysmal positional vertigo as a common public health problem. Ann Med Health Sci Res. 2015 Jan-Feb;5(1):50-3. doi: 10.4103/2141-9248.149788. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who had normal vestibular response to provocative tests 7 days after re-positioning maneuver Every patient with BPPV who had positional nystagmus during Dix-Hallpike and head-roll provocative maneuvers will be treated with Epley or barbeque particle re-positioning maneuvers. Balance (positional nystagmus) of patients 7 days after re-positioning maneuvers will be assessed. 7 days Yes
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