Measurement of Substance P in Saliva of Low Back Pain Patients

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735735
• Other study ID #: FK 26
• Status: Terminated
• Phase: N/A
• Start date: February 2009
• Est. completion date: March 2014

Study information

• Verified date: August 2019
• Source: Kovacs Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Kovacs Foundation	Palma de Mallorca	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of Substance P in the saliva		12 months