Benign Paroxysmal Positional VertigoNCT03854084
Cranial Osteopathic Techniques on the Symptoms of Benign Paroxysmal Positional Vertigo
A study testing The cranial osteopathic techniques in people with Benign Paroxysmal Positional Vertigo, run by Laiana Sepúlveda de Andrade Mesquita at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- The cranial osteopathic techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Dec 2017to 23 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Were included in the study male and female individuals with age range between 25 and 45 years, BPPV positives.
Who cannot join
- The exclusion criteria were being in use of any medication for vertigo treatment and the presence of any infectious pathology or deformity in the inner ear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Cranial Osteopathic Techniques on the Symptoms of Benign Paroxysmal Positional Vertigo
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.
Read the detailed description
The vertigo is the illusive sensation of motion around the ambiance, results in disorders in the physical and social health of the patient due to difficulty in movement and coordination (CAMPOS et al, 2003) and it is classified as one of the four types of dizziness: syncope, disequilibrium, non-specific dizziness or lightheadedness and vertigo. The vertigo may have peripheral and central causes . In peripheral vertigo, its source situated in the labyrinth or in vestibular nerve, until your entrance in vestibular nuclei. In the central vertigo, its origin located in the vestibular nuclei, in brainstem or cerebellum.
Vestibular, visual and proprioceptive systems provides the balance. The vestibular system finds in the inner ear and consists of bony and membranous labyrinths. The entire set is placed in the petrous part of the temporal bones where it is located the cochlea (structure involved in hearing), three semicircular canals and the vestibule. The bony labyrinth contains the perilymph, which has electrolytic function analogous to extracellular wall, additionally, fulfills the tympanic and vestibular cavities. The membranous labyrinth consists of endolymph and ciliated structures sensitive to its movement (otoliths), located in the ampulla (terminal portion of the semicircular canals) which are susceptible to positional changes in the head . The vestibule has sensory organs (utricle and saccule) which assists the ciliated cells monitoring the position of the head. Such structures contain calcium carbonate crystals, responsive to acceleration and gravity effect.
Pereira highlights that vestibulo-ocular reflex uses the information from the sensory organs of the inner ear - saccule and utricle - to generate compensatory movements to position of the head on extraocular muscles. The anterior inferior cerebellar artery, a branch originate in the basilar artery, supplies the whole vestibular system.
With regards to balance, it is significantly important understand the anatomic relation of the vestibule with the vestibular reflexes which consists the visual and proprioceptive systems. All the information derived from the semicircular canals and from the otoliths (saccule and utricle) reaches the cerebellum and the vestibular nuclei as of afferent fibers of vestibular nerve. The processing and integration of central nervous system with the afferent signals from vestibular, visual and proprioceptive systems allows to produce the vestibulo-ocular (maintains the compensatory movement of the eyes regarding the movement from the head), vestibulospinal (produces dynamic and static strategies related to posture), cervico-ocular (steadies the neck through information received from vestibule) reflexes.
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). This process induces an abnormal acceleration of endolymph, providing a response to central nervous system that the head is spinning leading to the symptoms and characteristics of BPPV: sudden changes in the position of the head, such as rolling over the bed or tilting the head may causes quick episodes of vertigo, which lasts between 30 seconds to 2 minutes following, or not, of nystagmus, not associated with auditory problems.
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.
The osteopathy concerning to skull had their first records by William G. Sutherland, and it is treated as an extension of the principles of the applied osteopathy in the cranial bones. In his study of the so-called Craniosacral Therapy, Sutherland presuppose that exists a primary respiratory movement, which depends on rhythmic pressure changes induced by alteration of the venous pressure inside the medullary cavity, which causes the pressure of the cerebrospinal fluid varies, of the tensions in the reciprocal membranes, which are the falx cerebri (sagittal) and the cerebellar tentorium (transverse). These membranes are connected to sacrum through the dura mater.
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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- The cranial osteopathic techniques, Control group
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cranial osteopathic techniquesOther
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.
Control groupOther
Simulation of the techniques was used in the interventional group
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The cranial osteopathic techniques Receives: Other: The cranial osteopathic techniques |
| control group | Sham comparator | Control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start14 Dec 2017
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laiana Sepúlveda de Andrade Mesquita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laiana Sepúlveda de Andrade Mesquita, Universidade Estadual do PiauÍ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854084
- Sponsor's protocol ID
- FDAAA 801
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Cranial Osteopathic Techniques on the Symptoms of Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT03854084
- Acronym / sponsor ID
- FDAAA 801
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laiana Sepúlveda de Andrade MesquitaUniversity, hospital or other
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The vertigo is the illusive sensation of motion around the ambiance, results in disorders in the physical and social health of the patient due to difficulty in movement and coordination (CAMPOS et al, 2003) and it is classified as one of the four types of dizziness: syncope, disequilibrium, non-specific dizziness or lightheadedness and vertigo. The vertigo may have peripheral and central causes . In peripheral vertigo, its source situated in the labyrinth or in vestibular nerve, until your entrance in vestibular nuclei. In the central vertigo, its origin located in the vestibular nuclei, in brainstem or cerebellum.
Vestibular, visual and proprioceptive systems provides the balance. The vestibular system finds in the inner ear and consists of bony and membranous labyrinths. The entire set is placed in the petrous part of the temporal bones where it is located the cochlea (structure involved in hearing), three semicircular canals and the vestibule. The bony labyrinth contains the perilymph, which has electrolytic function analogous to extracellular wall, additionally, fulfills the tympanic and vestibular cavities. The membranous labyrinth consists of endolymph and ciliated structures sensitive to its movement (otoliths), located in the ampulla (terminal portion of the semicircular canals) which are susceptible to positional changes in the head . The vestibule has sensory organs (utricle and saccule) which assists the ciliated cells monitoring the position of the head. Such structures contain calcium carbonate crystals, responsive to acceleration and gravity effect.
Pereira highlights that vestibulo-ocular reflex uses the information from the sensory organs of the inner ear - saccule and utricle - to generate compensatory movements to position of the head on extraocular muscles. The anterior inferior cerebellar artery, a branch originate in the basilar artery, supplies the whole vestibular system.
With regards to balance, it is significantly important understand the anatomic relation of the vestibule with the vestibular reflexes which consists the visual and proprioceptive systems. All the information derived from the semicircular canals and from the otoliths (saccule and utricle) reaches the cerebellum and the vestibular nuclei as of afferent fibers of vestibular nerve. The processing and integration of central nervous system with the afferent signals from vestibular, visual and proprioceptive systems allows to produce the vestibulo-ocular (maintains the compensatory movement of the eyes regarding the movement from the head), vestibulospinal (produces dynamic and static strategies related to posture), cervico-ocular (steadies the neck through information received from vestibule) reflexes.
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). This process induces an abnormal acceleration of endolymph, providing a response to central nervous system that the head is spinning leading to the symptoms and characteristics of BPPV: sudden changes in the position of the head, such as rolling over the bed or tilting the head may causes quick episodes of vertigo, which lasts between 30 seconds to 2 minutes following, or not, of nystagmus, not associated with auditory problems.
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.
The osteopathy concerning to skull had their first records by William G. Sutherland, and it is treated as an extension of the principles of the applied osteopathy in the cranial bones. In his study of the so-called Craniosacral Therapy, Sutherland presuppose that exists a primary respiratory movement, which depends on rhythmic pressure changes induced by alteration of the venous pressure inside the medullary cavity, which causes the pressure of the cerebrospinal fluid varies, of the tensions in the reciprocal membranes, which are the falx cerebri (sagittal) and the cerebellar tentorium (transverse). These membranes are connected to sacrum through the dura mater.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: The cranial osteopathic techniquesThe cranial osteopathic techniques |
| control group | Sham comparator | Other: Control groupControl group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Were included in the study male and female individuals with age range between 25 and 45 years, BPPV positives.
Key exclusion criteria (1 listed)
- The exclusion criteria were being in use of any medication for vertigo treatment and the presence of any infectious pathology or deformity in the inner ear.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The cranial osteopathic techniquesTechnique 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. | Other | Intervention group |
| Control groupSimulation of the techniques was used in the interventional group | Other | control group |
Primary outcome
Dix-Hallpike test
Time frame: 5 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cranial osteopathic techniques in people with Benign Paroxysmal Positional Vertigo, run by Laiana Sepúlveda de Andrade Mesquita at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dix-Hallpike test (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.