Study of Low Back Pain Using CERSR® Imaging Technology

July 29, 2011 updated by: Verium Diagnostics, Inc.

Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44304-1619
        • Summa Center for Clinical Trials
      • Akron, Ohio, United States, 44310-3110
        • Summa St. Thomas Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Subjects who do not currently have low back pain.
Group B
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment (day 1 - baseline) and four weeks and eight weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verium Diagnostics, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

August 1, 2011

Last Update Submitted That Met QC Criteria

July 29, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMI-2010-002
  • RP# 11002 (Other Identifier: Summa Health Systems IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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