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Akron, Ohio 44310


Purpose:

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 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.


Study summary:

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 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention. The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain. 2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.


Criteria:

Inclusion Criteria Groups A, B and C: 1. Male and female employees of the study center. 2. Between the ages of 18 and 70 years. 3. Current employees as well as new hires. Exclusion Criteria Group A: 1. Low back pain. Exclusion Criteria Group B: 1. Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit. 2. Pregnant. 3. Sensitivity to isopropyl alcohol used to prepare the low back surface. 4. Inability to complete the required collection positions for the CERSR® scan. 5. Inability or unwillingness to adhere to the protocol and follow-up schedule. 6. Anyone under care of a physician for active liability or workman compensation cases. 7. Anyone who has had an open spinal procedure in the last three months. 8. Anyone who has undergone spine injections within the last two months. Exclusion Criteria Group C: 1. Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit 2. Pregnant. 3. Sensitivity to isopropyl alcohol used to prepare the low back surface. 4. Inability to complete the required collection positions for the CERSR scan. 5. Inability or unwillingness to adhere to the protocol and follow-up schedule. 6. Anyone under care of a physician for active liability or workman compensation cases. 7. Anyone who has had an open spinal procedure in the last three months. 8. Anyone who has undergone spine injections within the last two months. 9. Anyone who is currently undergoing physical therapy or chiropractic treatments.


NCT ID:

NCT01401660


Primary Contact:

Principal Investigator
Nilesh Shah, M.D.
Summa Health Systems


Backup Contact:

N/A


Location Contact:

Akron, Ohio 44310
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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