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Status unknownNCT01995279EARPIBUpdated Nov 26, 2013

Ear Acupuncture Reducing Pain and Improving Balance

An interventional study of French ear acupuncture and Sham Ultrasound in Chronic Low Back Pain, sponsored by Universidade Cruzeiro do Sul. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by Universidade Cruzeiro do Sul · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Low Back Pain

Keywords

  • low back pain
  • French Auriculotherapy
  • postural control
  • balance
  • posture
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 80 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Universidade Cruzeiro do Sul is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • Placebo comparator
    Sham Ultrasound

    Sham ultrasound will be applied at lumbar spine.

    Other: Sham Ultrasound

Interventions

  • DeviceFrench ear acupuncture

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

    Also known as: Auriculotherapy

  • OtherSham Ultrasound

    Ultrasound turned off.

    Also known as: Ultrasound

06

What researchers measure

Primary outcomes

  1. 11-point Short Pain Scale (SPS-11)

    Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

    Time frame: 20 minute

Secondary outcomes

  1. Center of pressure sway area

    Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

    Time frame: 20 minute

07

Study locations

1 of 1 sites recruiting
  • Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul
    São Paulo, SP 01506-000, Brazil
    • Paulo B de Freitas, PhD · Contact · deFreitasPB@gmail.com · +55(11)3385-3103
    • Bianca P Cunha, PT, MSc · Sub investigator
    • Andrea Ushinohama, PT · Principal investigator
    Recruiting
08

References and documents

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. PubMed 27556389 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01995279
Lead sponsor
Universidade Cruzeiro do Sul
Responsible party
Paulo Barbosa de Freitas Junior (Associate Professor, Universidade Cruzeiro do Sul) — Principal investigator
First posted
Nov 26, 2013
Start date
Nov 2013
Primary completion
Mar 2014 (estimated)
Completion
Mar 2014 (estimated)
Last update
Nov 26, 2013

Study contacts

Paulo B de Freitas, PhD
principal investigator · Associate Professor, Universidade Cruzeiro do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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