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)

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. Identifier: NCT01458938
Recruitment Status : Terminated (Study will need to be redesigned for improved efficacy.)
First Posted : October 25, 2011
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
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.

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

Study Type : Observational
Actual Enrollment : 53 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

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

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 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

Responsible Party: Carolina Neurosurgery & Spine Associates Identifier: NCT01458938     History of Changes
Other Study ID Numbers: Substance P
First Posted: October 25, 2011    Key Record Dates
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