Study of Low Back Pain Using CERSR® Imaging Technology

Verium Diagnostics, Inc.290 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

290

Conditions

Low Back Pain

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change from Baseline in Pain Visual Analog Scale

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.

Time frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks

Secondary Outcomes

Change from Baseline Oswestry Disability Index (ODI)

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.

Time frame: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks