VertigoNCT05118659
Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo
A study testing sustained natural apophyseal glides in people with Vertigo, run by Centro Universitario La Salle at 2 sites in Spain.
Trial summary
This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Vertigo
- What is being tested?
- sustained natural apophyseal glides
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesSpain
- Study dates
- 3 Feb 2018to 28 Jun 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 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects,
- Age 18-44 years.
Who cannot join
- Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
- Hippoacusia
- Auditory diseases
- Peripheral or central vestibulopathies
- Cerviogenic dizziness
- Balance disorders
Show all 15Show fewer
- Nistagmus
- Oculomotor nerve dysfunctions
- Migraine
- Cervical osteoporosis, lashing or fracture
- Discal cervical hernia
- Cervical neuropathy
- Psychriatic disorders
- Epilepsy
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study
This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.
- Conditions
- Vertigo
- Being tested
- sustained natural apophyseal glides, SHAM SNAG
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sustained natural apophyseal glidesProcedure or surgery
Also called SNAG
It consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each
SHAM SNAGProcedure or surgery
Subjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension
| Study group | Role | What they receive |
|---|---|---|
| SNAG GROUP | Experimental | The SNAG group received a treatment based on sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each, combined with active cervical extension. Receives: Procedure: sustained natural apophyseal glides |
| SHAM SNAG GROUP | Sham comparator | The placebo SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension. Receives: Procedure: SHAM SNAG |
| CONTROL GROUP | No intervention | The control group did not receive any type of intervention, they only waited for four minutes, sat down on a chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
vHIT (Video Head Impulse Test)
Detection of peripheral vestibular deficits and their recovery
Measured: 15 minutes
Secondary outcomes (1)
Anxiety
state-trait anxiety was measured at the beginning of the study using the Spanish version of the trait-state anxiety inventory (STAI)
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start3 Feb 2018
- Primary completion4 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Vicente Leon Hernandez, Centro Universitario La Salle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118659
- Sponsor's protocol ID
- CSEULS-PI-198/2018
- Status last verified
- Nov 2021
- First submitted
- 19 Oct 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be treated by study researchers
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mulligan Therapy Effects In Healthy Subjects With Induced Vertigo. A Randomized And Controlled Clinic Study
- ClinicalTrials.gov ID
- NCT05118659
- Acronym / sponsor ID
- CSEULS-PI-198/2018
- Conditions
- Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Study start
- 3 Feb 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 12 Nov 2021 (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.
This analysis aims to evaluate the immediate effect that cervical sustained natural apophyseal glides (SNAGs) have on a group of individuals with induced vertigo by a caloric vestibular stimulation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNAG GROUP | Experimental | Procedure: sustained natural apophyseal glidesThe SNAG group received a treatment based on sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each, combined with active cervical extension. |
| SHAM SNAG GROUP | Sham comparator | Procedure: SHAM SNAGThe placebo SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension. |
| CONTROL GROUP | No intervention | –The control group did not receive any type of intervention, they only waited for four minutes, sat down on a chair |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects,
- Age 18-44 years.
Key exclusion criteria (15 listed)
- Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
- Hippoacusia
- Auditory diseases
- Peripheral or central vestibulopathies
- Cerviogenic dizziness
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 |
|---|---|---|
| sustained natural apophyseal glidesAlso: SNAGIt consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each | Procedure or surgery | SNAG GROUP |
| SHAM SNAGSubjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension | Procedure or surgery | SHAM SNAG GROUP |
Primary outcome
vHIT (Video Head Impulse Test)
Time frame: 15 minutes
Detection of peripheral vestibular deficits and their recovery
1 secondary outcome
Anxiety
Time frame: 5 minutes
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 12 Nov 2021.
- Individual participant dataSharing planned: No. Data will only be treated by study researchers
Related trials for Vertigo
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Recruiting
Incremental Vestibulo-ocular Reflex Adaptation as a Novel Treatment for Dizziness in People With Multiple Sclerosis
Multiple Sclerosis
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sustained natural apophyseal glides in people with Vertigo, run by Centro Universitario La Salle at 2 sites in Spain.
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 2 inclusion and 15 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
vHIT (Video Head Impulse Test) (time frame: 15 minutes). 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 12 Nov 2021.