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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. (Substance P)

This study has been terminated.
(Study will need to be redesigned for improved efficacy.)
ClinicalTrials.gov Identifier:
First Posted: October 25, 2011
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carolina Neurosurgery & Spine Associates
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.

Condition Intervention
Spinal Disease Spinal Radiculopathy Myelopathy Neurogenic Claudication Other: treatment plan

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study

Resource links provided by NLM:

Further study details as provided by Carolina Neurosurgery & Spine Associates:

Primary Outcome Measures:
  • Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study [ Time Frame: 2009-2014 ]
    Study was closed pending re-design at some future date to improve efficacy.

Biospecimen Retention:   Samples Without DNA
Blood, saliva and cerebrospinal fluid

Enrollment: 53
Study Start Date: July 2009
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers
surgery for spinal radiculopathy Other: treatment plan
Data Collection Study
surgery for axial spine pain Other: treatment plan
Data Collection Study
myelography for spinal pain Other: treatment plan
Data Collection Study


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary care clinic

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458938

United States, North Carolina
Carolina Neurosurgery and Spine Associates, P.A.
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Carolina Neurosurgery & Spine Associates
Principal Investigator: Vinay Deshmukh, M.D. Carolina Neurosurgery & Spine Associates
  More Information

Responsible Party: Carolina Neurosurgery & Spine Associates
ClinicalTrials.gov Identifier: NCT01458938     History of Changes
Other Study ID Numbers: Substance P
First Submitted: October 24, 2011
First Posted: October 25, 2011
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Spinal Cord Diseases
Spinal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Central Nervous System Diseases
Bone Diseases
Musculoskeletal Diseases
Substance P
Neurokinin A
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs