Spinal DiseaseSubstance PNCT01458938
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.
An observational study of Spinal Disease and Spinal Radiculopathy, run by Carolina Neurosurgery & Spine Associates at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Disease, Spinal Radiculopathy, Myelopathy
- What is being tested?
- treatment plan
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- Previous spinal procedures or operations,
- radicular pain,
- history of fibromyalgia,
- chronic pain,
- rheumatoid arthritis,
- autoimmune disorders,
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- HIV,
- PTSD,
- Major Depressive Disorder,
- migraine headaches or active rhinosinusitis,
- nicotine intake
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Neurosurgery and Spine Associates, P.A.
Charlotte, North Carolina, 28204
About this study
Official title: 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.
- Being tested
- treatment plan
- Medical subject headings
- Spinal Diseases, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment planOther
Data Collection Study
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described | |
| surgery for spinal radiculopathy | Not described Receives: Other: treatment plan | |
| surgery for axial spine pain | Not described Receives: Other: treatment plan | |
| myelography for spinal pain | Not described Receives: Other: treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2009-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startJul 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study will need to be redesigned for improved efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Neurosurgery & Spine Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vinay Deshmukh, M.D., Principal investigator, Carolina Neurosurgery & Spine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458938
- Sponsor's protocol ID
- Substance P
- Acronym
- Substance P
- Status last verified
- Jan 2017
- First submitted
- 24 Oct 2011
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance P Neuropeptide Levels in Saliva, Serum and Cerebrospinal Fluid in Patients With Spinal Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT01458938
- Acronym / sponsor ID
- Substance P / Substance P
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study will need to be redesigned for improved efficacy.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Carolina Neurosurgery & Spine AssociatesUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | – |
| surgery for spinal radiculopathy | – | Other: treatment plan |
| surgery for axial spine pain | – | Other: treatment plan |
| myelography for spinal pain | – | Other: treatment plan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Previous spinal procedures or operations,
- radicular pain,
- history of fibromyalgia,
- chronic pain,
- rheumatoid arthritis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment planData Collection Study | Other | myelography for spinal pain, surgery for axial spine pain, surgery for spinal radiculopathy |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Study will need to be redesigned for improved efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay Deshmukh, M.D. principal investigator
Carolina Neurosurgery & Spine Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disease and Spinal Radiculopathy, run by Carolina Neurosurgery & Spine Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study will need to be redesigned for improved efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance P Neuropeptide Levels in Saliva And Serum in Patients with Spinal Disease: A Pilot Study (time frame: 2009-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.