Post Market Study of the Electrophysiological Course of Low Back Pain Using CERSR Technology

This study has been terminated.
(Company no longer has funding for the study.)
Sponsor:
Information provided by (Responsible Party):
Verium Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01403870
First received: July 25, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

The purpose of this research study is:

  1. to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back during the treatment of the low back pain, and
  2. to study the changes which take place in these muscles with treatment. The device is non-invasive which means nothing is put into your body. The CERSR® pad is an adhesive (sticky) array (ordered rows) of electrodes.

The investigators hope to find information about the quality of the muscles' electrical signals in reaction to injury causing back pain, which will improve understanding of the nature of back pain and back injury. The investigators also hope to improve treatment by creating a simple test, which will tell us objectively (through computerized measurement) whether the treatment is helping.


Condition Intervention
Low Back Pain
Other: Physical Therapy

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

Resource links provided by NLM:


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 the 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 (ODI) 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 the ODI scores will be analyzed.


Enrollment: 6
Study Start Date: April 2011
Groups/Cohorts Assigned Interventions
Low Back Pain Subjects
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Test subjects will be recruited from individuals who are currently have Volusia Health Network (VHN) medical coverage.

Criteria

Inclusion Criteria:

  1. Male and female who have VHN medical coverage.
  2. Between the ages of 18 and 70

Exclusion Criteria:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403870

Locations
United States, Florida
Orthopaedic Clinic of Daytona Beach
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Verium Diagnostics, Inc.
Investigators
Principal Investigator: Mark Gillespy, M.D. Orthopaedic Clinic of Daytona Beach
  More Information

Additional Information:
Publications:
Responsible Party: Verium Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01403870     History of Changes
Other Study ID Numbers: 2011-001
Study First Received: July 25, 2011
Last Updated: November 17, 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 September 18, 2014