An observational study in Back Pain, sponsored by Texas Tech University Health Sciences Center. Terminated. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by Texas Tech University Health Sciences Center · Observational
The investigators are doing this study to learn more about the cause of back pain with or without pain shooting down one or both legs. The investigators specifically want to know if cells that move into injured areas of the body are present in a space in the spine (epidural space) of patients with back pain and with or without shooting pain. The investigators will collect cells when patients are being treated, then examine the cells using a microscope. The investigators also will shine different colors of light into the epidural space to see if there is a correlation between how different colors of light are reflected and the types of cells present.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 605 is above the median of 100 across 357 observational studies indexed under Back Pain.
Browse Back Pain studies →Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
consecutive patients receiving epidural neurolysis treatment for back pain
Exclusion Criteria:
Characteristics of cell samples
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
Time frame: 5 years
Reflect light
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
Time frame: 10 years
No study locations are listed for this record.
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center