Measurement of Substance P in Saliva of Low Back Pain Patients

This study is currently recruiting participants.

Verified by Kovacs Foundation, May 2009

First Received: August 14, 2008 Last Updated: May 27, 2009 History of Changes

Sponsored by:	Kovacs Foundation
Information provided by:	Kovacs Foundation
ClinicalTrials.gov Identifier:	NCT00735735

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:	Diagnostic, Single Blind (Investigator), Historical Control, Parallel Assignment
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:

Higher levels of Substance P in the saliva of subjects with severe chronic low back pain. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (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, Balearic Islands
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:	Kovacs Foundation ( Francisco M. Kovacs, Director of Scientific Department )
Study ID Numbers:	FK 26
Study First Received:	August 14, 2008
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00735735 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Kovacs Foundation:

low back pain
chronic
Substance P

Study placed in the following topic categories:

Signs and Symptoms
Neurotransmitter Agents
Neurologic Manifestations
Low Back Pain

Pain
Back Pain
Substance P

Additional relevant MeSH terms:

Signs and Symptoms
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Neurologic Manifestations

Low Back Pain
Pain
Back Pain
Pharmacologic Actions
Substance P

ClinicalTrials.gov processed this record on September 04, 2009