Ear Acupuncture Reducing Pain and Improving Balance

Study Overview
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Brief Summary
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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.

Official Title
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The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Device: French ear acupuncture
* Other: Sham Ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: French ear acupuncture<br>Application of single session of French ear acupuncture at specific points used to reduce low back pain. | Device: French ear acupuncture<br>* Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.<br>* Other names: Auriculotherapy;|
| Placebo Comparator: Sham Ultrasound<br>Sham ultrasound will be applied at lumbar spine. | Other: Sham Ultrasound<br>* Ultrasound turned off.<br>* Other names: Ultrasound;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point Short Pain Scale (SPS-11) | Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound | 20 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of pressure sway area | Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound | 20 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, French Auriculotherapy, postural control, balance, posture