Measurement of Substance P in Saliva of Low Back Pain Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2009 by Kovacs Foundation.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Kovacs Foundation

ClinicalTrials.gov Identifier:

NCT00735735

First received: August 14, 2008

Last updated: June 26, 2011

Last verified: December 2009

History of Changes

Purpose

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.

Condition	Intervention
Low Back Pain	Other: The taking of a saliva sample from each subject.

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic
Official Title:	Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Further study details as provided by Kovacs Foundation:

Primary Outcome Measures:

Levels of Substance P in the saliva [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Subjects with pain that is additional to or different from chronic low back pain

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735735

Contacts

Contact: Francisco M Kovacs, MD, PhD	+34 971 720809	kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH	+34 91 3440244	mtgildelreal@kovacs.org

Locations

Spain
Kovacs Foundation	Recruiting
Palma de Mallorca, Balearic Islands, Spain, 07012
Contact: Francisco M Kovacs, MD, PhD +34 971 720809 kovacs@kovacs.org
Contact: María Teresa Gil del Real, MPH +34 91 3440244 mtgildelreal@kovacs.org
Principal Investigator: Francisco M Kovacs, MD, PhD
Sub-Investigator: Mario Gestoso, MD

Sponsors and Collaborators

Kovacs Foundation

Investigators

Study Director:	Francisco M Kovacs, MD, PhD	Kovacs Foundation, Palma de Mallorca, 07012, Spain
Principal Investigator:	Mario Gestoso, MD	Kovacs Foundation,Palma de Mallorca, Spain

More Information

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.

Morton 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.

Kowalski 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.

Thomas 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.

Responsible Party:	Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00735735 History of Changes
Other Study ID Numbers:	FK 26
Study First Received:	August 14, 2008
Last Updated:	June 26, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Kovacs Foundation:

low back pain
chronic
Substance P

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Substance P
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013

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