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.

Terminated

• Conditions: Myelopathy; Neurogenic Claudication; Spinal Disease; Spinal Radiculopathy
• Interventions: Other: treatment plan

• Registration Number: NCT01458938
• Lead Sponsor: Carolina Neurosurgery & Spine Associates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-25
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
surgery for axial spine pain	treatment plan	-
myelography for spinal pain	treatment plan	-
surgery for spinal radiculopathy	treatment plan	-

Primary Outcome Measures

Name	Time	Method
Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study	2009-2014	Study was closed pending re-design at some future date to improve efficacy.

Trial Locations

Locations (1)

Carolina Neurosurgery and Spine Associates, P.A.; 🇺🇸 Charlotte, North Carolina, United States