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Cytology Study of Cells From Patients With Low Back Pain

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT01089478
First received: March 17, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition
Back Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cells in the Lumbar Epidural Space of Patients With Low Back Pain and/or Radiculopathy

Resource links provided by NLM:


Further study details as provided by Texas Tech University Health Sciences Center:

Primary Outcome Measures:
  • Characteristics of cell samples [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Reflect light [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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

During epiduroscopy up to five (5) specimen samples will be collected from different sites in the epidural space


Enrollment: 605
Study Start Date: April 2005
Estimated Study Completion Date: October 2014
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

consecutive patients receiving epidural neurolysis treatment for back pain

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089478

Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
Principal Investigator: James E Heavner, DVM, PhD Texas Tech University Health Sciences Center
  More Information

No publications provided

Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01089478     History of Changes
Other Study ID Numbers: L05-099
Study First Received: March 17, 2010
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Tech University Health Sciences Center:
Back pain
Low back pain
Cytology
Epiduroscopy
Pain
Radiculopathy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014