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.

NCT01458938 | Terminated DMC

• 1 other identifier: Substance P
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Disease; Spinal Radiculopathy; Myelopathy; Neurogenic Claudication

Outcome Measures

Primary Outcomes (1)

• Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study

  Study was closed pending re-design at some future date to improve efficacy.

  2009-2014

Study Arms (4)

Healthy volunteers

surgery for spinal radiculopathy

Other: treatment plan

surgery for axial spine pain

Other: treatment plan

myelography for spinal pain

Other: treatment plan

Interventions

treatment plan OTHER

Data Collection Study

myelography for spinal pain; surgery for axial spine pain; surgery for spinal radiculopathy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carolina Neurosurgery & Spine Associates: lead

Study Sites (1)

Carolina Neurosurgery and Spine Associates, P.A.

Charlotte, North Carolina, 28204, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, saliva and cerebrospinal fluid

MeSH Terms

Conditions

Spinal Diseases; Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vinay Deshmukh, M.D.

  Carolina Neurosurgery & Spine Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: October 25, 2011
• Study Start: July 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

US (1)