Measurement of Substance P in Saliva of Low Back Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00735735
Recruitment Status : Suspended
First Posted : August 15, 2008
Last Update Posted : March 13, 2014
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation

Brief 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. The ultimate objective would be to design a measurement method for use in routine clinical practice.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: The taking of a saliva sample from each subject. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain
Study Start Date : February 2009
Actual Primary Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Intervention Details:
    Other: 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.

Primary Outcome Measures :
  1. Levels of Substance P in the saliva [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00735735

Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
Sponsors and Collaborators
Kovacs Foundation
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

Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation Identifier: NCT00735735     History of Changes
Other Study ID Numbers: FK 26
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: March 13, 2014
Last Verified: March 2014

Keywords provided by Francisco M. Kovacs, Kovacs Foundation:
low back pain
Substance P

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance P
Neurokinin A
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs