Study of Low Back Pain Using CERSR® Imaging Technology
|ClinicalTrials.gov Identifier: NCT01401660|
Recruitment Status : Terminated (Principal Investigator withdrew from the study.)
First Posted : July 25, 2011
Last Update Posted : August 1, 2011
|Condition or disease||Intervention/treatment|
|Low Back Pain||Other: Physical Therapy|
|Study Type :||Observational|
|Estimated Enrollment :||290 participants|
|Official Title:||Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology|
|Study Start Date :||May 2011|
Subjects who do not currently have low back pain.
Subjects who have low back pain at the time of the study, and who are currently being treated or have been previously treated for their low back pain and do not wish to receive further treatment for their pain.
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.
- Change from Baseline in Pain Visual Analog Scale [ Time Frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks ]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 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 ]The subjects will complete the Oswestry Disability Index 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 ODI scores will be analyzed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401660
|United States, Ohio|
|Summa Center for Clinical Trials|
|Akron, Ohio, United States, 44304-1619|
|Summa St. Thomas Hospital|
|Akron, Ohio, United States, 44310-3110|
|Principal Investigator:||Nilesh Shah, M.D.||Summa Health Systems|