Measurement of Substance P in Saliva of Low Back Pain Patients

Kovacs Foundation40 enrolled

Overview

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 Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Low Back Pain

Interventions

The taking of a saliva sample from each subject.OTHER

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

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, Spain

Outcomes

Primary Outcomes

Levels of Substance P in the saliva

Time frame: 12 months

Data from ClinicalTrials.gov

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