Cytology Study of Cells From Patients With Low Back Pain

NCT01089478 | Terminated

• 1 other identifier: L05-099
• Study Type: observational
• Target: 605
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Back Pain

Keywords

Back pain; Low back pain; Cytology; Epiduroscopy; Pain; Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (1)

• Reflect light

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients receiving epidural neurolysis treatment for back pain

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Back Pain; Low Back Pain; Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• James E Heavner, DVM, PhD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: April 1, 2005
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: January 6, 2020

Record last verified: 2020-01