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Study of Low Back Pain Using CERSR® Imaging Technology

This study has been terminated.
(Principal Investigator withdrew from the study.)
Sponsor:
Information provided by:
Verium Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01401660
First received: March 29, 2011
Last updated: July 29, 2011
Last verified: July 2011
History of Changes
  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.


Condition Intervention
Low Back Pain
 Other: Physical Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Verium Diagnostics, Inc.:

Primary Outcome Measures:
  • Change from Baseline in Pain Visual Analog Scale [ Time Frame: Upon enrollment (day 1 - baseline) and four weeks and eight weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline Oswestry Disability Index (ODI) [ Time Frame: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 290
Study Start Date: May 2011
Groups/Cohorts Assigned Interventions
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.
Other Name: Physical Therapy

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401660

Locations
United States, Ohio
Summa St. Thomas Hospital
Akron, Ohio, United States, 44310-3110
Summa Center for Clinical Trials
Akron, Ohio, United States, 44304-1619
Sponsors and Collaborators
Verium Diagnostics, Inc.
Investigators
Principal Investigator: Nilesh Shah, M.D. Summa Health Systems
  More Information

Additional Information:
Sponsor Company Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Tamala J. Wampler / Vice President QA & RA, Verium Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01401660     History of Changes
Other Study ID Numbers: SMI-2010-002, RP# 11002
Study First Received: March 29, 2011
Last Updated: July 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Verium Diagnostics, Inc.:
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013