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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Substance P
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014