- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458938
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
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
-
-
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
|
Data Collection Study
|
surgery for axial spine pain
|
Data Collection Study
|
myelography for spinal pain
|
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.
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.
Clinical Trials on Myelopathy
-
National Institute of Neurological Disorders and...CompletedMyelopathy | AIDS-Myelopathy | AIDS Vacuolar MyelopathyUnited States
-
Peking University Third HospitalCompleted
-
Shanghai Changzheng HospitalRecruitingMyelopathy CervicalChina
-
Cambridge University Hospitals NHS Foundation TrustNational Institute for Health Research, United Kingdom; Wolfson Brain Imaging...RecruitingCervical Spondylosis With Myelopathy | Degenerative Cervical MyelopathyUnited Kingdom
-
University of KentuckyRecruiting
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
University of UtahEnrolling by invitationCervical MyelopathyUnited States
-
The University of Hong KongCompleted
-
The University of Hong KongThe Hong Kong Polytechnic UniversityCompletedCervical MyelopathyHong Kong
-
Istanbul UniversityCompleted
Clinical Trials on treatment plan
-
University of California, San FranciscoWashington University School of Medicine; University of Washington; Pacific Pediatric... and other collaboratorsRecruitingMedulloblastoma | Medulloblastoma, Childhood | Medulloblastoma RecurrentUnited States
-
Chinese Academy of SciencesCity of Hope Medical Center; Fifth Affiliated Hospital, Sun Yat-Sen University and other collaboratorsRecruitingGastrointestinal Neoplasm MalignantUnited States, China, Germany, Italy
-
Tianjin First Central HospitalShenzhen Third People's HospitalNot yet recruiting
-
University Hospital HeidelbergRecruiting
-
Medical College of WisconsinNot yet recruiting
-
Fondazione Italiana Linfomi ONLUSCompletedDiffuse Large B Cell LymphomaItaly
-
Tianjin Medical University Second HospitalRecruiting
-
IRCCS Ospedale San RaffaeleEnrolling by invitation
-
University of Illinois at ChicagoNational Institute on Aging (NIA)CompletedEncephalopathy, Ischemic
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterVA Mental Illness Research, Education and Clinical CentersCompletedCannabis Dependence | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Dependence | Opiate DependenceUnited States