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 Associates

Status: Terminated

Conditions: Spinal Disease; Spinal Radiculopathy; Myelopathy; Neurogenic Claudication

Treatments: Other: treatment plan

Study type: Observational

Funder types: Other

Identifiers

NCT01458938

Substance P

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

53 participants in 4 patient groups

Healthy volunteers

surgery for spinal radiculopathy

Treatment:

Other: treatment plan

surgery for axial spine pain

Treatment:

Other: treatment plan

myelography for spinal pain

Treatment:

Other: treatment plan