Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for study group:
- •Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o
排除标准
- •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
研究组 & 干预措施
Study group
Participants with masticatory muscle pain lasting for over 3 months.
干预措施: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination (Diagnostic Test)
Study group
Participants with masticatory muscle pain lasting for over 3 months.
干预措施: Blood test (Diagnostic Test)
Control group
Participants without masticatory muscle pain in last 6 months.
干预措施: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination (Diagnostic Test)
Control group
Participants without masticatory muscle pain in last 6 months.
干预措施: Blood test (Diagnostic Test)
结局指标
主要结局
Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
时间窗: January 3, 2023 - January 3, 2024
Each participant will undergo genetical blood test.
Relationship between masticatory muscle pain and serotonin and dopamine levels.
时间窗: 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.
时间窗: January 3, 2023 - January 3, 2024
Each participant will undergo blood test.
次要结局
- 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)
研究者
Joanna Smardz
Investigator
Wroclaw Medical University