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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01458938
Date of registration: 24/10/2011
Primary sponsor: Carolina Neurosurgery & Spine Associates
Public title: 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
Scientific title: Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study
Date of first enrolment: July 2009
Target sample size: 40
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT01458938
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Vinay Deshmukh, M.D.
Address: 
Telephone:
Email:
Affiliation:  Carolina Neurosurgery & Spine Associates
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Myelopathy
Neurogenic Claudication
Spinal Disease,
Spinal Radiculopathy,
Intervention(s)
Other: treatment plan
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Substance P
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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