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.

Spinal Disease Clinical Trial

— Substance P  

Official title:

Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01458938
• Other study ID #: Substance P
• Status: Terminated
• Phase: N/A
• First received: October 24, 2011
• Last updated: January 30, 2017
• Start date: July 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2017
• Source: Carolina Neurosurgery & Spine Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Myelopathy
• Neurogenic Claudication
• Radiculopathy
• Spinal Cord Diseases
• Spinal Disease
• Spinal Diseases
• Spinal Radiculopathy

Intervention

Other:
• treatment plan
Data Collection Study

Locations

Country	Name	City	State
United States	Carolina Neurosurgery and Spine Associates, P.A.	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Carolina Neurosurgery & Spine Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2009-2014