Study of Cells From Spinal Cavity of Patients With Low Back Pain

NCT01089491 | Withdrawn

• 1 other identifier: L10-081
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study to determine if cells collected give us information about what is causing a patient pain can be detected and connected with epiduroscopy images (pictures taken with a small fiber optic scope). We want to determine if abnormal areas are the source of that pain by using a catheter to provide a brief, low intensity electrical stimulation. We also want to determine if there are cells in the epidural cavity (area surrounding the spinal cord) of patients who have low back pain with or without pain shooting down one or both legs that provide information about what is causing the pain.

Conditions

Low Back Pain

Keywords

Low back pain; Epiduroscopy; Cytology; Electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Characteristics of cell types

  We 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. We expect the cells will indicate that a pathological process is present and will provide information about the characteristics of the process.

  6 months

Secondary Outcomes (1)

• Electrical stimulation to locate pain

  6 months to 1 year

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 outpatient lysis of adhesions treatment at University Medical Center in Lubbock TX.

You may qualify if:

• Understand and voluntarily sign the informed consent and HIPAA forms
• Age \>18 years at the time of signing the informed consent
• Scheduled for epiduroscopy assisted epidural neurolysis
• A diagnosis of low back pain with or without radiculopathy

You may not qualify if:

• Not scheduled for epiduroscopy assisted epidural neurolysis

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Up to two (2) cell samples will be collected from different sites in the epidural space

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 18, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (1)