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

NCT01403870 | Terminated

• 1 other identifier: 2011-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is:

1. 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. 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.

Conditions

Low Back Pain

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Pain Visual Analog Scale

  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.

  Upon enrollment (day 1 - baseline) and four weeks and eight weeks

Secondary Outcomes (1)

• Change from Baseline Oswestry Disability Index (ODI)

  Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks

Study Arms (1)

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

Interventions

Physical Therapy OTHER

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.

Low Back Pain Subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit
• Pregnant
• Sensitivity to isopropyl alcohol used to prepare the low back surface
• Inability to complete the required collection positions for the CERSR® scan
• Inability or unwillingness to adhere to the protocol and follow-up schedule
• Anyone under care of a physician for active liability or workman compensation cases.
• Anyone who has had an open spinal procedure in the last three months.
• Anyone who has undergone spine injections within the last two months.
• Anyone who is currently undergoing physical therapy or chiropractic treatments.

Sponsors & Collaborators

• Verium Diagnostics, Inc.: lead

Study Sites (1)

Orthopaedic Clinic of Daytona Beach

Daytona Beach, Florida, 32117, United States

Location

Related Publications (1)

• 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.

  PMID: 12838104 RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Mark Gillespy, M.D.

  Orthopaedic Clinic of Daytona Beach

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: April 1, 2011
• Last Updated: November 18, 2011

Record last verified: 2011-11

Locations

US (1)