Clinical trial NCT01401660: Study of Low Back Pain Using CERSR® Imaging Technology
Official title: Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Low Back Pain
Keywords: low back pain
Lead sponsor: Verium Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-25
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will be selected from employees of Summa Health System. Current employees as well as new hires will be eligible to participate in the study.

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change from Baseline in Pain Visual Analog Scale
timeFrame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks
Secondary outcomes:
measure: Change from Baseline Oswestry Disability Index (ODI)
timeFrame: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Center for Clinical Trials
state: Ohio
city: Akron
country: United States
facility: Summa St. Thomas Hospital
state: Ohio
Study officials:
affiliation: Summa Health Systems
name: Nilesh Shah, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finneran MT, Mazanec D, Marsolais ME, Marsolais EB, Pease WS. Large-array surface electromyography in low back pain: a pilot study. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1447-54. doi: 10.1097/01.BRS.0000067565.16832.B9.