Ear Acupuncture Reducing Pain and Improving Balance

Chronic Low Back Pain Clinical Trial

— EARPIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01995279
• Other study ID #: UCS_EA
• Status: Recruiting
• Phase: N/A
• First received: November 21, 2013
• Last updated: November 25, 2013
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2013
• Source: Universidade Cruzeiro do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Low Back Pain

Intervention

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

Other:
• Sham Ultrasound
Ultrasound turned off.

Locations

Country	Name	City	State
Brazil	Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cruzeiro do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	11-point Short Pain Scale (SPS-11)	Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound	20 minute	No
Secondary	Center of pressure sway area	Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound	20 minute	No