Measurement of Substance P in Saliva of Low Back Pain Patients

August 22, 2019 updated by: Francisco M. Kovacs, Kovacs Foundation

Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07012
        • Kovacs Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Levels of Substance P in the saliva
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FK 26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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