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Measurement of Substance P in Saliva of Low Back Pain Patients

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00735735
Enrollment
40
Registered
2008-08-15
Start date
2009-02-28
Completion date
2014-03-31
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, chronic, Substance P

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.

Interventions

OTHERThe 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.

Sponsors

Kovacs Foundation
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Levels of Substance P in the saliva12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026