NCT05118659

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 12, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

October 19, 2021

Last Update Submit

November 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • vHIT (Video Head Impulse Test)

    Detection of peripheral vestibular deficits and their recovery

    15 minutes

Secondary Outcomes (1)

  • Anxiety

    5 minutes

Study Arms (3)

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.

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.

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

Interventions

It consists on a sustained apophyseal glides in a postero-anterior direction on C2 with a dose of three series of ten repetitions each

Also known as: SNAG
SNAG GROUP
SHAM SNAGPROCEDURE

Subjects on SNAG group received a simulation of the contact used for the SNAGs, without any vertebral glide, and with an active cervical extension

SHAM SNAG GROUP

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects,
  • Age 18-44 years.

You may not qualify if:

  • Consume of antipsychotics, antidepressants, antiarrythmics and/or anticonvulsivants
  • Hippoacusia
  • Auditory diseases
  • Peripheral or central vestibulopathies
  • Cerviogenic dizziness
  • Balance disorders
  • Nistagmus
  • Oculomotor nerve dysfunctions
  • Migraine
  • Cervical osteoporosis, lashing or fracture
  • Discal cervical hernia
  • Cervical neuropathy
  • Psychriatic disorders
  • Epilepsy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CSEU La Salle

Madrid, 28023, Spain

Location

Jose V Leon Hernandez

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Vertigo

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 12, 2021

Study Start

February 3, 2018

Primary Completion

June 4, 2018

Study Completion

June 28, 2018

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Data will only be treated by study researchers

Locations