Salivary Inflammatory Markers in Tension Type Headache and Migraine

NCT03727672 | Unknown

• 1 other identifier: 638/5.11.2015
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Data role of salivary inflammatory markers in migraine and Tension Type headache (TTH) are lacking. Τhe investigators studied whether headache attacks are associated with changes in C reactive protein (CRP), Interleukin -1β and Interleukin -6 in saliva in patients with Tension Type Headache and Migraine and age matched healthy controls . Τhe investigators, also investigated whether these markers could be influenced by comorbidities such as depression and anxiety.

Conditions

Migraine; Tension-Type Headache

Keywords

Primary headaches; CRP; Interleukin1β; Interleukin6; markers

Outcome Measures

Primary Outcomes (3)

• migraine/Tension type Headache and C reactive protein

  establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of C reactive protein

  2 years

• migraine/Tension type Headache and Interleukin -1β

  establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of Interleukin-1β

  2 years

• migraine/Tension type Headache and Interleukin-6 levels

  establish whether attacks of migraine and Tension type Headache are associated with changes in the concentration of Interleukin-6 levels

  2 years

Secondary Outcomes (5)

• C reactive protein concentrations

  2 years

• Interleukin-1β concentrations

  2 years

• Interleukin-6 levels concentrations

  2,5 years

• Anxiety

  2,5 years

• Depression

  2,5 years

Study Arms (3)

Tension type headache patients

30 subjects of both genders, aged from 18 to 60 years old, with primary headaches (TTH) , according to the International Classification of Headache Disorders, 3rd edition (beta version) , were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016.

Migraine patients

30 subjects of both genders, aged from 18 to 60 years old, with migraine, according to the International Classification of Headache Disorders, 3rd edition (beta version) , were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016.

age matched controls

30 healthy control subjects aged matched were recruited mainly from hospital staff and patients' relatives

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of both genders, aged from 18 to 60 years old, with primary headaches TTH and migraine, according to the International Classification of Headache Disorders, 3rd edition (beta version), were enrolled from the outpatient headache clinic of the first Neurological Hospital of University of Athens between January to March 2016. Fifteen healthy control subjects aged matched were recruited mainly from hospital staff and patients' relatives

You may qualify if:

• aged from 18 to 60 years old
• Tension type Headache (TTH) and migraine, fulfilling the criteria International Classification of Headache Disorders, 3rd edition (beta version)

You may not qualify if:

• abnormal plasma CRP, Interleukin-1β and Interleukin-6 levels (\>10 mg/L)
• smoking cigarettes \> 1 pack/day;
• current pregnancy, lactation, or hormonal contraceptive use
• alcohol or substance abuse
• drug use such as anticoagulants, statins, or hormonal drugs
• anti-inflammatory therapy
• other primary or secondary headaches
• major psychiatric disease
• oral health problems.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Eginition Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

Athens, 11528, Greece

Location

Related Publications (1)

• Sjogren E, Leanderson P, Kristenson M, Ernerudh J. Interleukin-6 levels in relation to psychosocial factors: studies on serum, saliva, and in vitro production by blood mononuclear cells. Brain Behav Immun. 2006 May;20(3):270-8. doi: 10.1016/j.bbi.2005.08.001. Epub 2005 Sep 23.

  PMID: 16183246 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Saliva transferrin levels were measured by competitive immunoassay kits and Interleukin-6, Interleukin-1β and CRP levels were measured by sandwich ELISA kits.

MeSH Terms

Conditions

Migraine Disorders; Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ANASTASIA BOUGEA, PHD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 1, 2018
• Study Start: January 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

GR (1)