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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.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Carolina Neurosurgery & Spine Associates
ClinicalTrials.gov Identifier:
NCT01458938
First received: October 24, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

Biospecimen Retention:   Samples Without DNA

Blood, saliva and cerebrospinal fluid


Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458938

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

No publications provided

Responsible Party: Carolina Neurosurgery & Spine Associates
ClinicalTrials.gov Identifier: NCT01458938     History of Changes
Other Study ID Numbers: Substance P
Study First Received: October 24, 2011
Last Updated: September 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Spinal Diseases
Radiculopathy
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases
 Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Substance P
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013