Ear Acupuncture Reducing Pain and Improving Balance (EARPIB)

November 25, 2013 updated by: Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul

The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance

The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain.

We hypothesize that:

I) The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain.

II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment.

III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01506-000
        • Recruiting
        • Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul
        • Contact:
        • Sub-Investigator:
          • Bianca P Cunha, PT, MSc
        • Principal Investigator:
          • Andrea Ushinohama, PT

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complaints of back pain lasting more than 12 weeks
  • Pain referred larger than 4 according to the 11-points pain scale

Exclusion Criteria:

  • No other musculoskeletal injury,
  • Individuals diagnosed with structural damage
  • Individuals who performed a spine surgery
  • Individuals who have sensory abnormalities or dizziness.
  • Individuals may not be in physical therapy for reducing low back pain.
  • Painkillers or anti-inflammatories use 24 hours before the experimental procedure.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: French ear acupuncture
Application of single session of French ear acupuncture at specific points used to reduce low back pain.
Device: French ear acupuncture
Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.
Other Names:
  • Auriculotherapy
Placebo Comparator: Sham Ultrasound
Sham ultrasound will be applied at lumbar spine.
Other: Sham Ultrasound
Ultrasound turned off.
Other Names:
  • Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
11-point Short Pain Scale (SPS-11)
Time Frame: 20 minute
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
20 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center of pressure sway area
Time Frame: 20 minute
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
20 minute

Collaborators and Investigators

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

Sponsor

Universidade Cruzeiro do Sul

Investigators

  • Principal Investigator: Paulo B de Freitas, PhD, Associate Professor, Universidade Cruzeiro do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

November 21, 2013

First Submitted That Met QC Criteria

November 25, 2013

First Posted (Estimate)

November 26, 2013

Study Record Updates

Last Update Posted (Estimate)

November 26, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCS_EA

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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