Набор по приглашению NCT05676827

Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain

— Наблюдательное TMD Masticatory Muscle Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination, Blood test.
Кому может быть актуально: Состояния в реестре: TMD, Masticatory Muscle Pain. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Польша
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Диагностический тест Diagnostic Criteria for Temporomandibular Disorders Clinical Examination
Clinical examination made by experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the DC/TMD.
Диагностический тест Blood test
Blood samples will be tested to investigate two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) and levels of 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.

Первичные конечные точки

Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280 [Срок оценки: January 3, 2023 - January 3, 2024]
Relationship between masticatory muscle pain and serotonin and dopamine levels. [Срок оценки: January 3, 2023 - January 3, 2024]
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. [Срок оценки: January 3, 2023 - January 3, 2024]

Вторичные конечные точки (8)

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

Критерии участия

Inclusion Criteria for study group:

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

Критерии исключения

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: