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Ear Acupuncture Reducing Pain and Improving Balance (EARPIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995279
Recruitment Status : Unknown
Verified November 2013 by Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul.
Recruitment status was:  Recruiting
First Posted : November 26, 2013
Last Update Posted : November 26, 2013
Sponsor:
Information provided by (Responsible Party):
Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Device: French ear acupuncture Other: Sham Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance
Study Start Date : November 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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 Name: Auriculotherapy

Placebo Comparator: Sham Ultrasound
Sham ultrasound will be applied at lumbar spine.
Other: Sham Ultrasound
Ultrasound turned off.
Other Name: Ultrasound




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Center of pressure sway area [ Time Frame: 20 minute ]
    Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995279


Locations
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Brazil
Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul Recruiting
São Paulo, SP, Brazil, 01506-000
Contact: Paulo B de Freitas, PhD    +55(11)3385-3103    deFreitasPB@gmail.com   
Sub-Investigator: Bianca P Cunha, PT, MSc         
Principal Investigator: Andrea Ushinohama, PT         
Sponsors and Collaborators
Universidade Cruzeiro do Sul
Investigators
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Principal Investigator: Paulo B de Freitas, PhD Associate Professor, Universidade Cruzeiro do Sul
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Paulo Barbosa de Freitas Junior, Associate Professor, Universidade Cruzeiro do Sul
ClinicalTrials.gov Identifier: NCT01995279    
Other Study ID Numbers: UCS_EA
First Posted: November 26, 2013    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2013
Keywords provided by Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul:
low back pain
French Auriculotherapy
postural control
balance
posture
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms