Measurement of Substance P in Saliva of Low Back Pain Patients

NCT00735735 | Terminated DMC

• 1 other identifier: FK 26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; chronic; Substance P

Outcome Measures

Primary Outcomes (1)

• Levels of Substance P in the saliva

  12 months

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with pain that is additional to or different from chronic low back pain

Sponsors & Collaborators

• Kovacs Foundation: lead

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Related Publications (4)

• 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.

  PMID: 2162020 BACKGROUND

• 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.

  PMID: 2480554 BACKGROUND

• 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.

  PMID: 1696295 BACKGROUND

• 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.

  PMID: 2469033 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Francisco M Kovacs, MD, PhD

  Kovacs Foundation, Palma de Mallorca, 07012, Spain

  STUDY DIRECTOR

• Mario Gestoso, MD

  Kovacs Foundation,Palma de Mallorca, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Scientific Department, Kovacs Foundation

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

ES (1)