Low Back PainNCT00735735
Measurement of Substance P in Saliva of Low Back Pain Patients
A study testing The taking of a saliva sample from each subject. in people with Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
Trial summary
The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- The taking of a saliva sample from each subject.
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2009to Mar 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
- A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
- Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)
- For healthy subjects:
- Volunteers with no pain (anywhere)
- That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.
Who cannot join
- Subjects with pain that is additional to or different from chronic low back pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain
The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.
- Conditions
- Low Back Pain
- Being tested
- The taking of a saliva sample from each subject.
- Keywords
- low back pain, chronic, Substance P
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The taking of a saliva sample from each subject.Other
After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Substance P in the saliva
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainMario Gestoso, MD, Principal investigator, Kovacs Foundation,Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735735
- Sponsor's protocol ID
- FK 26
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2008
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
LeVasseur SA, Gibson SJ, Helme RD. The measurement of capsaicin-sensitive sensory nerve fiber function in elderly patients with pain. Pain. 1990 Apr;41(1):19-25. doi: 10.1016/0304-3959(90)91104-Q.
PubMed 2162020Morton CR, Hutchison WD. Release of sensory neuropeptides in the spinal cord: studies with calcitonin gene-related peptide and galanin. Neuroscience. 1989;31(3):807-15. doi: 10.1016/0306-4522(89)90443-0.
PubMed 2480554Kowalski ML, Sliwinska-Kowalska M, Kaliner MA. Neurogenic inflammation, vascular permeability, and mast cells. II. Additional evidence indicating that mast cells are not involved in neurogenic inflammation. J Immunol. 1990 Aug 15;145(4):1214-21.
PubMed 1696295Thomas KL, Andrews PV, Khalil Z, Helme RD. Substance P induced hydrolysis of inositol phospholipids in rat skin in an in vivo model of inflammation. Neuropeptides. 1989 Apr;13(3):191-6. doi: 10.1016/0143-4179(89)90091-7.
PubMed 2469033
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT00735735
- Acronym / sponsor ID
- FK 26
- Conditions
- Low Back Pain
- Keywords
- low back pain, chronic, Substance P
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Aug 2008 (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 purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
- A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
- Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)
- Volunteers with no pain (anywhere)
- That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.
Key exclusion criteria (1 listed)
- Subjects with pain that is additional to or different from chronic low back pain
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 |
|---|---|---|
| The taking of a saliva sample from each subject.After taking the sample, the saliva will be transferred via a pipette to a clean tube which will be labeled with the subject's name, the date and the hour. Once a month the tubes will be sent to the collaborating laboratory for analysis. | Other | – |
Primary outcome
Levels of Substance P in the saliva
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 2162020LeVasseur SA, Gibson SJ, Helme RD. The measurement of capsaicin-sensitive sensory nerve fiber function in elderly patients with pain. Pain. 1990 Apr;41(1):19-25. doi: 10.1016/0304-3959(90)91104-Q.
- Background: PubMed 2480554Morton CR, Hutchison WD. Release of sensory neuropeptides in the spinal cord: studies with calcitonin gene-related peptide and galanin. Neuroscience. 1989;31(3):807-15. doi: 10.1016/0306-4522(89)90443-0.
- Background: PubMed 1696295Kowalski ML, Sliwinska-Kowalska M, Kaliner MA. Neurogenic inflammation, vascular permeability, and mast cells. II. Additional evidence indicating that mast cells are not involved in neurogenic inflammation. J Immunol. 1990 Aug 15;145(4):1214-21.
- Background: PubMed 2469033Thomas KL, Andrews PV, Khalil Z, Helme RD. Substance P induced hydrolysis of inositol phospholipids in rat skin in an in vivo model of inflammation. Neuropeptides. 1989 Apr;13(3):191-6. doi: 10.1016/0143-4179(89)90091-7.
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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.
Francisco M Kovacs, MD, PhD study director
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Mario Gestoso, MD principal investigator
Kovacs Foundation,Palma de Mallorca, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The taking of a saliva sample from each subject. in people with Low Back Pain, run by Kovacs Foundation at 1 site in Spain.
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 6 inclusion and 1 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 28 Aug 2019. 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 Spain. 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. 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?
Levels of Substance P in the saliva (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735735, which also lists 4 linked publications.
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 28 Aug 2019.