Study of Cells From Spinal Cavity of Patients With Low Back Pain
Study of Cells From Spinal Cavity of Patients With Low Back Pain
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.
The pain group at TTUSOM has pioneered a treatment for low back pain with or without
 radiculopathy called epidural neurolysis (or other names, e.g.: lysis of epidural adhesions,
 the Racz procedure). This technique is now used worldwide. The treatment is based on
 substantial evidence that pathological processes within the epidural space innate and sustain
 pain. The goal of epidural neurolysis is to deposit therapeutic agents directly into the area
 of pathology (i.e., targeted drug delivery). The procedure involves documentation via
 epidurograms that radio opaque material injected into the epidural space prior to treatment
 does not enter the suspected area of pathology. This area is determined by signs and symptoms
 revealed by the patient history and physical examination.

 After a filling defect that corresponds to the suspected area of pathology is documented by
 epidurography, a specially designed catheter is directed into the defect. Mechanical forces
 applied by the catheter and hydraulic forces applied by injection of isotonic saline through
 the catheter as well as injection of hyaluronidase, are used to enter and remove barriers to
 targeted delivery of drug. Next drugs, usually corticosteroid, local anesthetic and
 hypertonic saline, are injected to treat what is presumed to be inflammation and edema.

 More recently, epiduroscopy has been introduced as an aid to epidural neurolysis.
 Epiduroscopy allows visual inspection of epidural tissue. Epiduroscopy is performed by
 inserting a flexible endoscope through the sacral hiatus. Using epiduroscopy, we and others
 have observed change in the epidural space that we believe are related to the etiology of the
 pain. We see changes consistent with various stages of inflammation either acute or chronic.
 We see increases in vascularity, displacement of fat by fibrous tissue as well as changes in
 the texture and color of peridural fat.

 We have developed a method for retrieving cells from suspected areas of pathology and of
 culturing the cells via the working channel of the epiduroscope using a cytology brush. The
 collected cells are characterized to establish a diagnosis and to aid treatment.

 To confirm areas which appear to be abnormal when viewed via epiduroscopy are involved in the
 painful condition for which the patient is seeking treatment, we test the area with
 hydrostatic pressure (saline injection) or by touching with the epiduroscope tip (mechanical
 stimulation). These stimuli do not normally elicit pain. However, when the stimulus does
 elicit pain in the region of the painful region of the patient's body, the abnormal appearing
 tissue in the epidural space is considered to be involved in painful process affecting the
 patient. This is similar to "pain mapping" done by others when electrical stimulation is used
 to search for the area of pathology. Adapting this approach, applying electrical stimulation
 via a stimulating probe (FDA approved) inserted through the working channel of the
 epiduroscope will allow more precise localization of pathological tissue than does the
 methods we currently use.

 We will collect cells during epiduroscopy and characterize them in vitro. A new dimension of
 this project is to deliver electrical stimulation to more accurately locate the source of
 pain from where cells should be sampled.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  Not scheduled for epiduroscopy assisted epidural neurolysis

 -  In the opinion of the investigator, the patient's overall condition is not suitable
 for inclusion