Study of Low Back Pain Using CERSR® Imaging Technology

Verium Diagnostics

Status: Terminated

Conditions: Low Back Pain

Treatments: Other: Physical Therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01401660

RP# 11002 (Other Identifier)

SMI-2010-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

290 participants in 3 patient groups

Group A

Description:

Subjects who do not currently have low back pain.

Group B

Description:

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.

Group C

Description:

Subjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain.

Treatment:

Other: Physical Therapy