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Clinical Trial 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.


Clinical Trial 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 Index and determination of following blood substances: serotonin, dopamine, acetylcholine, adrenaline, noradrenaline, cortisol, parathyroid hormone, CRP, fibrinogen, interleukin 1B, interleukin 6 and interleukin 8. Additionally the level of electrolytes in the blood (Mg, Ca, Na, K) and level of phosphate will be measured. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05676827
Study type Observational
Source Wroclaw Medical University
Contact
Status Enrolling by invitation
Phase
Start date September 1, 2023
Completion date December 2025

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