Measurement of Substance P in Saliva of Low Back Pain Patients

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Francisco M. Kovacs, Kovacs Foundation
ClinicalTrials.gov Identifier:
NCT00735735
First received: August 14, 2008
Last updated: March 11, 2014
Last verified: March 2014
  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:


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
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.
  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

Locations
Spain
Kovacs Foundation
Palma de Mallorca, Balearic Islands, Spain, 07012
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:
Responsible Party: Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs Foundation
ClinicalTrials.gov Identifier: NCT00735735     History of Changes
Other Study ID Numbers: FK 26
Study First Received: August 14, 2008
Last Updated: March 11, 2014
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 April 17, 2014