NCT03854084

Brief Summary

The benign paroxysmal positional vertigo (BPPV) is a type of peripheral vertigo characterized by the accumulation of otoliths debris, which are particles resulted from the condensation of endolymph in the inner ducts of semicircular canals (duct lithiasis or canalithiasis). In order to detect the BPPV, a simple test is utilized. The Dix-Hallpike test consists in lay the individual in a quick change in the position of the head. The maneuver is performed, essentially, towards the side in which the patient alleges dizziness in the course of the change in the position of the head. If the individual report vertigo related or no to nystagmus, the test is considered as positive . The osteopathy is a science, which has specific methods of diagnosis and treatment, and has begun to be developed by the physician Andrew Taylor Still at the end of 19th century, which aim is to rebalance the activities of the organism. Accord to the osteopathy science, all the physiological structures in the organism integrating and requires functional and structural harmonization in order to improve the health of the whole body. The main objective of the treatment is to obtain the intertissue mobility, which is considered by osteopathy as a somatic dysfunction, when it is restricted. Samutt confirms that cranial dysfunction of the temporal bones in internal/external rotation may modify the orientation of the semicircular canals, provoking vertigo. Liem propose that the mobilization of the eyeball may be a sensory stimulus of the vestibulo-ocular pathways. For him, maneuvers to the eyeball assists to balance the tonus of extraocular muscles and creates fascial influences on the optic nerve and the oculomotor, and, thus, stimulates the vestibular nuclei. It also suggests that the tension of the cerebellar tentorium and the mobilization of the temporal bones have effects on the structures that composes the vestibule. Thereby, the present work investigated the effect of the cranial osteopathic techniques on the Benign Paroxysmal Positional Vertigo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 17, 2019

Last Update Submit

February 25, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dix-Hallpike test

    consists in provoke a sudden change of position: with the eyes open and looking forward; shifts quickly from the sitting position with the head leaning 45 degrees to one of the sides, with the head hanging. Sits again and perform the same procedure to the opposite side. The maneuver is executed initially to the side where the patient related dizziness while the change of the position of the head. When the individual is not able to recognize in which side the dizziness occurs, the investigators have begun the maneuver on the right side, in order to standardize the test. All the stages of the test must be performed with 40 seconds gap (CAMPOS et al., 2006; HERDMAN; 2003).

    5 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

The cranial osteopathic techniques

Other: The cranial osteopathic techniques

control group

SHAM COMPARATOR

Control group

Other: Control group

Interventions

Technique of the temporal bones in favor of the free movement. Ear Pull technique: the hands of the osteopath holds the auricle of the individual with the thumb, index and the middle finger in a tweezer shape and with the elbows resting over the stretcher. Ruddy technique: The osteopath puts the thumbs on the eyelid of each eyeball.

Intervention group

Simulation of the techniques was used in the interventional group

control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Were included in the study male and female individuals with age range between 25 and 45 years, BPPV positives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laiana Sepúlveda de Andrade Mesquita

Teresina, Piauí, 64052-580, Brazil

Location

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Control Groups

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 26, 2019

Study Start

December 14, 2017

Primary Completion

March 23, 2018

Study Completion

March 23, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations