Post Market Study of the Electrophysiological Course of Low Back Pain Using CERSR Technology
The purpose of this research study is:
- 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
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post Market Study of the Electrophysiological Course of Low Back Pain Using CERSR Technology|
- Change from Baseline in Pain Visual Analog Scale [ Time Frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks ] [ Designated as safety issue: No ]The subjects will complete a form indicating their pain level upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up VAS. Upon completion of the study the change in the VAS scores will be analyzed.
- Change from Baseline Oswestry Disability Index (ODI) [ Time Frame: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks ] [ Designated as safety issue: No ]The subjects will complete the Oswestry Disability Index (ODI) upon enrollment. Subjects will then be scanned again at four weeks and at eight weeks. At the time of the scan subjects will also be asked to complete a follow up ODI. Upon completion of the study the change in the ODI scores will be analyzed.
|Study Start Date:||April 2011|
Low Back Pain Subjects
Subjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain.
Other: Physical Therapy
The physician will complete a physical exam as well as analyze a completed CERSR scan study to determine the root cause of the low back pain. The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain.
Other Name: Physical Therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01403870
|United States, Florida|
|Orthopaedic Clinic of Daytona Beach|
|Daytona Beach, Florida, United States, 32117|
|Principal Investigator:||Mark Gillespy, M.D.||Orthopaedic Clinic of Daytona Beach|