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)

January 30, 2017 updated by: Carolina Neurosurgery & Spine Associates

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Associates, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2009-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carolina Neurosurgery & Spine Associates

Investigators

  • Principal Investigator: Vinay Deshmukh, M.D., Carolina NeuroSurgery & Spine Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

October 24, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (ESTIMATE)

October 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Substance P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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