Skip to main content
Clinical Trials/NCT05676827
NCT05676827
Enrolling By Invitation
Not Applicable

Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain

Wroclaw Medical University1 site in 1 country102 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Diagnostic Criteria for Temporomandibular Disorders Clinical Examination
Conditions
Not specified
Sponsor
Wroclaw Medical University
Enrollment
102
Locations
1
Primary Endpoint
Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

Brief Summary

The aim of this study is to investigate the relationship of psychological aspects, selected blood parameters, pain, central sensitization, and muscle electromyography activity in patients with chronic masticatory muscle pain.

Detailed Description

In this prospective cohort study, the study group will consist of 51 people with masticatory muscle pain lasting longer than 3 months, while the control group will involve 51 people without such disorder. Muscle type of temporomandibular disorders will be diagnosed on the basis of validated and standardized DC/TMD protocol. Additionally potential headaches will be assessed according to the ICHD-3, since coexistence of chronic masticatory muscle pain and headache is often observed. Psychological aspects will be analyzed using validated questionnaires regarding depression (PHQ-9), anxiety (GAD-7), perceived stress (PSS-10), satisfaction with life (SWLS), type D personality (DS-14) and coping with stress (Mini-COPE). Central Sensitization will be assessed using the Central Sensitization Inventory. Following blood substances will be assessed: serotonin, dopamine, Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A. Additionally two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) will be analyzed. Pain assessment will be done using a validated and standardized questionnaire regarding chronic pain (GCPS) and an algometer and will include the measurement of pressure pain threshold in masseter and temporal muscles. In addition, potential autonomic disorders will be assessed using Autonomic Symptoms Questionnaire proposed by Low. Electromyographic muscle activity will be assessed by tetany test. The results of the study will allow for deeper understanding of the complex nature of orofacial pain of muscle origin and its connection with the mechanism of central sensitization, headache and muscle electromyographic activity. Measurement of blood parameters will provide more accurate information on the pathophysiology of these disorders and the use of validated questionnaires will provide valuable information about the mental state of patients.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
December 1, 2026
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wroclaw Medical University
Responsible Party
Principal Investigator
Principal Investigator

Joanna Smardz

Investigator

Wroclaw Medical University

Eligibility Criteria

Inclusion Criteria

  • for study group:
  • Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o

Exclusion Criteria

  • severe neurological or psychiatric diseases, use of drugs that may affect the neuromuscular system, alcohol or drug addiction, cancer or pregnancy, previous head surgery
  • Inclusion criteria for control group:
  • no pain in masticatory muscles, age of at least 18 y.o Exclusion criteria the same as for study group

Arms & Interventions

Study group

Participants with masticatory muscle pain lasting for over 3 months.

Intervention: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination

Study group

Participants with masticatory muscle pain lasting for over 3 months.

Intervention: Blood test

Control group

Participants without masticatory muscle pain in last 6 months.

Intervention: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination

Control group

Participants without masticatory muscle pain in last 6 months.

Intervention: Blood test

Outcomes

Primary Outcomes

Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280

Time Frame: January 3, 2023 - January 3, 2024

Each participant will undergo genetical blood test.

Relationship between masticatory muscle pain and serotonin and dopamine levels.

Time Frame: January 3, 2023 - January 3, 2024

Each participant will undergo blood test.

Relationship between masticatory muscle pain and Gamma-aminobutyric acid (GABA), Tumor Necrosis Factor α (TNF-α), CGRP, SERT, interleukin 1B, interleukin 6, interleukin 8, interleukin 10 and interleukin 17A.

Time Frame: January 3, 2023 - January 3, 2024

Each participant will undergo blood test.

Secondary Outcomes

  • Relationship between masticatory muscle pain and PPTs.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and Type D personality assessed by DS-14 quesstionaire.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and coping with stress assessed by mini COPE.(January 3, 2023 - January 3, 2024)
  • Relationship between masticatory muscle pain and central sensitization assessed by Central Sensitization Inventory.(January 3, 2023 - January 3, 2024)

Study Sites (1)

Loading locations...

Similar Trials