Study of Low Back Pain Using CERSR® Imaging Technology

Terminated

• Conditions: Low Back Pain
• Interventions: Other: Physical Therapy

• Registration Number: NCT01401660
• Lead Sponsor: Verium Diagnostics, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2011-03-29
• Study Start: 2011-05
• Status Verified: 2011-07
• Study First Submitted QC: 2011-07-21
• Study First Posted: 2011-07-25
• Last Update Submitted: 2011-07-29
• Last Update Posted: 2011-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C	Physical Therapy	Subjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Pain Visual Analog Scale	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Oswestry Disability Index (ODI)	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.

Trial Locations

Locations (2)

Summa St. Thomas Hospital; 🇺🇸 Akron, Ohio, United States

Summa Center for Clinical Trials; 🇺🇸 Akron, Ohio, United States