Clinical trial NCT01089478: Cytology Study of Cells From Patients With Low Back Pain
Official title: Cells in the Lumbar Epidural Space of Patients With Low Back Pain and/or Radiculopathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Back Pain
Keywords: Back pain
Low back pain
Cytology
Epiduroscopy
Pain
Radiculopathy
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2010-03-18
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: consecutive patients receiving epidural neurolysis treatment for back pain

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Understand and voluntarily sign an informed consent form
* Age \>18 years at the time of signing the informed consent form
* A diagnosis of low back pain with or without radiculopathy and scheduled for epiduroscopy assisted epidural neurolysis

Exclusion Criteria:

* Patients not scheduled for epiduroscopy assisted epidural neurolysis
* Are female who is pregnant
* Are a female of childbearing age and are not using an acceptable form of contraception
* Have a medical history or condition that would not make the patient a good candidate for epiduroscopy procedure
* Are unwilling or unable to provide written informed consent and/or to obey the study procedures

Primary outcomes:
measure: Characteristics of cell samples
timeFrame: 5 years
Secondary outcomes:
measure: Reflect light
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: James E Heavner, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
References: