Effect of the Auricular Acupunture of the Lower Limbs on... | NCT03156530

Studies
Effect of the Auricular Acupunture of the Lower Limbs on the Equilibrium Response Evaluated by Static Stabilometry

NCT03156530

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Balance, Postural

Interventions

Auricular acupunture
Control

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2015Actual

Primary Completion Date

Mar 1, 2016Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

May 5, 2017

First Submission Date that Met QC Criteria

May 15, 2017

First Posted Date

May 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2017

Last Update Posted Date

May 17, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tamyris Padovani dos Santos, João Eduardo de Araujo, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

By using a static stabilometry platform, the investigators believe the possible verification of the efficiency of auricular acupuncture points that correlates with regions of our body that may interfere with static equilibrium.

The present work aims to analyze the effect of the stimulation of atrial points of the lower limbs on the equilibrium response evaluated by static stabilometry.

Detailed Description

Balance is an extremely relevant subject because of the large and increasing incidence of falls mainly in the elderly population. This leads to a significant social impact since falls can lead an elderly to increasing dependence on the family and can be the cause of depression and reduce their quality of life. Studies have already demonstrated the efficacy of acupuncture stimulation in the treatment of vertigo and also for the improvement of postural control. For this, the option of auricular acupuncture was chosen because it is a non-invasive and safe method. Thus, the objective of this study will be to analyze the effects of atrial stimulation of the lower limbs on the equilibrium response by static stabilometry. Participants in this study were 40 healthy individuals aged between 18 and 30 years who will be divided into two groups: GA (acupuncture group) (n = 20) and CG (control group) (n = 20). The acupuncture group will be stimulated unilaterally according to the motor preference side of each individual in the points referring to the three joints of the lower limb (knee and ankle hip). The control group will not receive stimulation. Balance evaluations will be performed before the stimuation (initial), 20 minutes after the initiation of the protocol (second evaluation) and 5 minutes after the second evaluation, with eyes open and closed. Participants will be positioned standing with their arms along their body, mouth closed not with force and parallel feet. Statistical analysis will be performed by means of a one-way analysis of variance (ANOVA) and the differences between the data will be evidenced by Holm Sidack's post-test. Values of p≤0.05 will be considered significant.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Auricular acupuncture	Experimental	Stimulated with needles at three joint points of the lower limb, knee and ankle. Balance assessments will be performed prior to (initial) pacing, 20 minutes after the initiation of the pacing protocol (second evaluation) and after 5 minutes the final evaluation.	Device: Auricular acupunture
Control	Placebo Comparator	Not receive stimulation.	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auricular acupunture	Device	Evaluation of balance before, during and after applying of auricular acupuncture.	Auricular acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of center of force through stabilometry	Evaluation shall be performed during the treatment period.	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

40 healthy individuals between the ages of 18 and 30

Exclusion Criteria:

Disorders of the central nervous system
Joint pathologies
Peripheral neuropathies

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

The subjects were randomized between the groups and the auricular stimulation was performed unilaterally, the motor preference side being standardized as the stimulated side

Who Masked

Not provided