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Ear Acupuncture Reducing Pain and Improving Balance (EARPIB)

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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

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date November 26, 2013
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Center of pressure sway area [ Time Frame: 20 minute ]
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ear Acupuncture Reducing Pain and Improving Balance
Official Title  ICMJE The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Device: French ear acupuncture
    Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.
    Other Name: Auriculotherapy
  • Other: Sham Ultrasound
    Ultrasound turned off.
    Other Name: Ultrasound
Study Arms  ICMJE
  • Experimental: French ear acupuncture
    Application of single session of French ear acupuncture at specific points used to reduce low back pain.
    Intervention: Device: French ear acupuncture
  • Placebo Comparator: Sham Ultrasound
    Sham ultrasound will be applied at lumbar spine.
    Intervention: Other: Sham Ultrasound
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995279
Other Study ID Numbers  ICMJE UCS_EA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul
Study Sponsor  ICMJE Universidade Cruzeiro do Sul
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paulo B de Freitas, PhD Associate Professor, Universidade Cruzeiro do Sul
PRS Account Universidade Cruzeiro do Sul
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP