Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-26 @ 11:53 AM
Study NCT ID:
NCT01401660
Status:
TERMINATED
Last Update Posted:
2011-08-01
First Post:
2011-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Low Back Pain Using CERSR® Imaging Technology
Sponsor:
Verium Diagnostics, Inc.
Organization:
Study Overview
Official Title:
Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
Status:
TERMINATED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator withdrew from the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RP# 11002 | OTHER | Summa Health Systems IRB | View |