NCT01995279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

November 21, 2013

Last Update Submit

November 25, 2013

Conditions

Chronic Low Back Pain

Keywords

low back painFrench Auriculotherapypostural controlbalanceposture

Outcome Measures

Primary Outcomes (1)

  • 11-point Short Pain Scale (SPS-11)

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

    20 minute

Secondary Outcomes (1)

  • Center of pressure sway area

    20 minute

Study Arms (2)

French ear acupuncture

EXPERIMENTAL

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

Device: French ear acupuncture

Sham Ultrasound

PLACEBO COMPARATOR

Sham ultrasound will be applied at lumbar spine.

Other: Sham Ultrasound

Interventions

French ear acupunctureDEVICE

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

Also known as: Auriculotherapy
French ear acupuncture
Sham UltrasoundOTHER

Ultrasound turned off.

Also known as: Ultrasound
Sham Ultrasound

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul

São Paulo, São Paulo, 01506-000, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27556389DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

AuriculotherapyHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Paulo B de Freitas, PhD

    Associate Professor, Universidade Cruzeiro do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 21, 2013

First Posted

November 26, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

BR(1)