TMD Clinical Trial - Pain, Central Sensitization & Psychoemotional State

Status Enrolling by invitation

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

Myalgia
TMD

Clinical Trial Details

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

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms