Intrathoracic placement of neurostimulation device

Postoperative Pain

Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.

Peripheral Nerve Stimulation

Cleveland Clinic

Feasibility Study for Intrathoracic Nerve Stimulation

Investigational Device Exemption for Intrathoracic Nerve Stimulation

Pain level expressed by the study subject in the scale of 0 (no pain) to 10 (unbearable pain). Lower scores represent the better outcome.

Freedom from device related adverse events (i.e., bleeding, infection, pneumothorax or arrhythmias)

Morphine equivalents taken during the inpatient period

Pain characteristics expressed by the study subject for the following criteria: Throbbing, Shooting, Stabbing, Sharp, Cramping, Gnawing, Hot/Burning, Aching, Heavy, Tender, Splitting, Tiring/Exhausting, Sickening, Fearful, Punishing/Cruel, with the following scales: 0=None, 1=Mild, 2=Moderate, and 3=Severe. Lower scores represent the better outcome.

Usman Ahmad, MD

Principal Investigator

The Cleveland Clinic

3 whole blood samples will be collected: before epiduroscopy, immediately after it and after a month for genetic analyses and cytokine dosage. An epidural bioptic sample will be performed according to usual clinical practice

Chronic Low Back Pain

University of Parma

Periduroscopy: Correlation Between the Outcome of Procedure and Histological-biochemical, Neuroinflammation and Genetic Factors.

A Prospective Study to Analyze, in a Population Undergoing to a Periduroscopy Approach, the Correlation Between Outcome of Procedure and Histological-biochemical Neuroinflammation and Genetic Factors

the frequency of rs1800795 in the promoter of the IL6 gene

other known variants related to inflammation in IL1β and IL6 loci

IL-6, IL-1β, IL1Ra and INFγ serum concentration before, immediately post epiduroscopy and after 1 month

IL-6, IL-1β, IL1Ra and INFγ gene expression in blood cells obtained before, immediately post epiduroscopy and after 1 month

IL-6, IL-1β, IL1Ra and INFγ gene expression in biopsy tissue cells

Guido Fanelli

Professor

IRCCS Policlinico S. Matteo

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

Low Back Pain

Texas Tech University Health Sciences Center

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

Localization and Characterization of Cells in the Lumbar Epidural Cavity of Patients With Low Back Pain With or Without Radiculopathy

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.

We expect that electrical stimulation will improve the precision with which abnormal, painful structures are localized and thereby improve collection of cells directly involved in the patient's pain.

low back pain/cárie dentária

Feasibility Study for Intrathoracic Nerve Stimulation

Periduroscopy: Correlation Between the Outcome of Procedure and Histological-biochemical, Neuroinflammation and Genetic Factors.

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

Clinical Outcome Study of Minimally Invasive Decompression for Lumbar Spinal Stenosis

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