Post Market Study of the Electrophysiological Course of Low Back Pain Using CERSR Technology

Stopped early

Conditions studied: Low Back Pain

In brief

The purpose of this research study is: 1. to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back during the treatment of the low back pain, and 2. to study the changes which take place in these muscles with treatment. The device is non-invasive which means nothing is put into your body. The CERSR® pad is an adhesive (sticky) array (ordered rows) of electrodes. The investigators hope to find information about the quality of the muscles' electrical signals in reaction to injury causing back pain, which will improve understanding of the nature of back pain and back injury. The investigators also hope to improve treatment by creating a simple test, which will tell us objectively (through computerized measurement) whether the treatment is helping.

Key facts

Study ID

NCT01403870

Run by

Verium Diagnostics, Inc.

People needed

6

Starts

2011-04-01

Last updated by the study team

2011-11-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female who have VHN medical coverage.
• Between the ages of 18 and 70

You may not qualify if…

• Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit
• Pregnant
• Sensitivity to isopropyl alcohol used to prepare the low back surface
• Inability to complete the required collection positions for the CERSR® scan
• Inability or unwillingness to adhere to the protocol and follow-up schedule
• Anyone under care of a physician for active liability or workman compensation cases.
• Anyone who has had an open spinal procedure in the last three months.
• Anyone who has undergone spine injections within the last two months.
• Anyone who is currently undergoing physical therapy or chiropractic treatments.

Where it is running

• Orthopaedic Clinic of Daytona Beach — Daytona Beach, Florida, United States

Full record on ClinicalTrials.gov

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