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Measurement of Substance P in Saliva of Low Back Pain Patients

Primary Purpose

Low Back Pain

Status

Terminated

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

The taking of a saliva sample from each subject.

About this trial

This is an interventional diagnostic trial for Low Back Pain focused on measuring low back pain, chronic, Substance P

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kovacs Foundation

Outcomes

Primary Outcome Measures

Levels of Substance P in the saliva

Secondary Outcome Measures

Full Information

NCT ID

NCT00735735

First Posted

August 14, 2008

Last Updated

August 22, 2019

Sponsor

Kovacs Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00735735

Brief Title

Measurement of Substance P in Saliva of Low Back Pain Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Study Start Date

February 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kovacs Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

low back pain, chronic, Substance P

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

The taking of a saliva sample from each subject.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Levels of Substance P in the saliva

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francisco M Kovacs, MD, PhD

Organizational Affiliation

Kovacs Foundation, Palma de Mallorca, 07012, Spain

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mario Gestoso, MD

Organizational Affiliation

Kovacs Foundation,Palma de Mallorca, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kovacs Foundation

City

Palma de Mallorca

State/Province

Balearic Islands

ZIP/Postal Code

07012

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

2162020

Citation

LeVasseur SA, Gibson SJ, Helme RD. The measurement of capsaicin-sensitive sensory nerve fiber function in elderly patients with pain. Pain. 1990 Apr;41(1):19-25. doi: 10.1016/0304-3959(90)91104-Q.

Results Reference

background

PubMed Identifier

2480554

Citation

Morton CR, Hutchison WD. Release of sensory neuropeptides in the spinal cord: studies with calcitonin gene-related peptide and galanin. Neuroscience. 1989;31(3):807-15. doi: 10.1016/0306-4522(89)90443-0.

Results Reference

background

PubMed Identifier

1696295

Citation

Kowalski ML, Sliwinska-Kowalska M, Kaliner MA. Neurogenic inflammation, vascular permeability, and mast cells. II. Additional evidence indicating that mast cells are not involved in neurogenic inflammation. J Immunol. 1990 Aug 15;145(4):1214-21.

Results Reference

background

PubMed Identifier

2469033

Citation

Thomas KL, Andrews PV, Khalil Z, Helme RD. Substance P induced hydrolysis of inositol phospholipids in rat skin in an in vivo model of inflammation. Neuropeptides. 1989 Apr;13(3):191-6. doi: 10.1016/0143-4179(89)90091-7.

Results Reference

background

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Measurement of Substance P in Saliva of Low Back Pain Patients

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