Cytology Study of Cells From Patients With Low Back Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01089478|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2010
Last Update Posted : January 19, 2018
|Condition or disease|
The objective of this study is to examine the cell population in the epidural space of patients with low back pain +/- radiculopathy to determine if the cell population reveals pathological processes sustaining the pain. Cells will be collected for microscopic inspection and will be examined in situ during exposure to white and UV light. The overall goal is to advance our knowledge about the etiology of low back pain +/- radiculopathy to guide mechanistic based therapy.
The primary information sought is to determine if description of pathological processes based upon direct observation with percutaneously placed epiduroscopes can be confirmed by cytological analysis. the observations described include: 1) increased fibrosis from slight to complete replacement of other tissue, or obliteration of the epidural space; 2) alteration of color and/or appearance of epidural fat; 3) increased or decreased vascularity. The overall description range from acute inflammatory changes to advanced fibrosis (scarring).
Specimens for cytological analysis will be obtained from different sites in the epidural space by using commercially available cytology specimen collecting brushes and/or catheters. These are inserted through the working channel of an epiduroscope into the lumbar epidural space to aid treatment.
|Study Type :||Observational|
|Actual Enrollment :||605 participants|
|Official Title:||Cells in the Lumbar Epidural Space of Patients With Low Back Pain and/or Radiculopathy|
|Study Start Date :||April 2005|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2018|
- Characteristics of cell samples [ Time Frame: 5 years ]The investigators expect that cell types identified will vary some from patient to patient depending in part upon how acute or chronic is the patient's disease and whether or not the patient has had prior surgery. The investigators expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process
- Reflect light [ Time Frame: 10 years ]The investigators expect that different tissue types in the epidural space will reflect white light differently and that some cells involved in pathological processes will autofluoresce
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089478
|Principal Investigator:||James E Heavner, DVM, PhD||Texas Tech University Health Sciences Center|