Study of Low Back Pain Using CERSR® Imaging Technology

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401660
• Other study ID #: SMI-2010-002
• Secondary ID: RP# 11002
• Status: Terminated
• Phase: N/A
• First received: March 29, 2011
• Last updated: July 29, 2011
• Start date: May 2011

Study information

• Verified date: July 2011
• Source: Verium Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 290
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Summa Center for Clinical Trials	Akron	Ohio
United States	Summa St. Thomas Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Verium Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Pease WS, Clairmont AC, Finneran MT. High resolution large-array surface electromyography in acute low back pain. White Paper

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 VAS scores will be analyzed.	Upon enrollment (day 1 - baseline) and four weeks and eight weeks	No
Secondary	Change from Baseline Oswestry Disability Index (ODI)	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	No