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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01458938

Acronym

Substance P

Enrollment

Registered

2011-10-25

Start date

2009-07-31

Completion date

2014-04-30

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Disease, Spinal Radiculopathy, Myelopathy, Neurogenic Claudication

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.

Interventions

OTHERtreatment plan

Data Collection Study

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study	2009-2014	Study was closed pending re-design at some future date to improve efficacy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026