This Study is to Determine if Degenerative Spinal Pain and Disorders Cause the Levels of Substance P to Change in a Patients Saliva, Blood and/or Cerebrospinal Fluid.

Carolina Neurosurgery & Spine Associates53 enrolled

Overview

The objective of this pilot study is to determine if degenerative spinal disorders such as acute radiculopathy, myelopathy, stenosis, or disc and facet disease cause detectable alterations in Substance P levels in saliva, serum and cerebrospinal fluid. If this pilot study shows a correlation between Substance P levels and pain associated with degenerative spinal disorders, then a larger study will be initiated to determine the feasibility of using Substance P levels in the diagnosis and treatment of degenerative spinal disease.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spinal Disease Spinal Radiculopathy Myelopathy Neurogenic Claudication

Interventions

treatment plan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing spinal surgery for medically refractory spinal radiculopathy, * myelopathy or neurogenic claudication based on either history, physical examination or radiologic studies demonstrating neural compression or degenerative disc disease. * Undergoing surgery for medically refractory axial spinal pain. Exclusion Criteria: * Previous spinal procedures or operations, * radicular pain, * history of fibromyalgia, * chronic pain, * rheumatoid arthritis, * autoimmune disorders, * HIV, * PTSD, * Major Depressive Disorder, * migraine headaches or active rhinosinusitis, * nicotine intake

Outcomes

Primary Outcomes

Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study

Study was closed pending re-design at some future date to improve efficacy.

Time frame: 2009-2014