EARPIB: Ear Acupuncture Reducing Pain and Improving Balance

Sponsor

Universidade Cruzeiro do Sul (Other)

Overall Status

Unknown status

CT.gov ID

NCT01995279

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.
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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2014

Anticipated Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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 Names:

Auriculotherapy

Placebo Comparator: Sham Ultrasound

Sham ultrasound will be applied at lumbar spine.

Other: Sham Ultrasound

Ultrasound turned off.

Other Names:

Ultrasound

Outcome Measures

Primary Outcome Measures

11-point Short Pain Scale (SPS-11) [20 minute]
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Secondary Outcome Measures

Center of pressure sway area [20 minute]
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.