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

May 15, 2017 updated by: Tamyris Padovani dos Santos, University of Sao Paulo

Auricular Acupuncture Versus Control Group in the Treatment of Balance: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 healthy individuals between the ages of 18 and 30

Exclusion Criteria:

  • Disorders of the central nervous system
  • Joint pathologies
  • Peripheral neuropathies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular acupuncture
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
Evaluation of balance before, during and after applying of auricular acupuncture.
Placebo Comparator: Control
Not receive stimulation.
Other: Control
Not receive stimulation.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 50015413300005440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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