Ear Acupuncture Reducing Pain and Improving Balance

NCT ID: NCT01995279

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain

Keywords

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low back pain French Auriculotherapy postural control balance posture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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French ear acupuncture

Application of single session of French ear acupuncture at specific points used to reduce low back pain.

Group Type EXPERIMENTAL

French ear acupuncture

Intervention Type DEVICE

Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.

Sham Ultrasound

Sham ultrasound will be applied at lumbar spine.

Group Type PLACEBO_COMPARATOR

Sham Ultrasound

Intervention Type OTHER

Ultrasound turned off.

Interventions

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French ear acupuncture

Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.

Intervention Type DEVICE

Sham Ultrasound

Ultrasound turned off.

Intervention Type OTHER

Other Intervention Names

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Auriculotherapy Ultrasound

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Cruzeiro do Sul

OTHER

Sponsor Role lead

Responsible Party

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Paulo Barbosa de Freitas Junior

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulo B de Freitas, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Universidade Cruzeiro do Sul

Locations

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Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Paulo B de Freitas, PhD

Role: primary

References

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Ushinohama A, Cunha BP, Costa LO, Barela AM, Freitas PB. Effect of a single session of ear acupuncture on pain intensity and postural control in individuals with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2016 Jul-Aug;20(4):328-35. doi: 10.1590/bjpt-rbf.2014.0158. Epub 2016 Jun 16.

Reference Type DERIVED
PMID: 27556389 (View on PubMed)

Other Identifiers

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UCS_EA

Identifier Type: -

Identifier Source: org_study_id