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

W

Wroclaw Medical University

Status

Invitation-only

Conditions

TMD
Masticatory Muscle Pain

Treatments

Diagnostic Test: Blood test
Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination

Study type

Observational

Funder types

Other

Identifiers

NCT05676827
WMU1/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

102 participants in 2 patient groups

Study group
Description:
Participants with masticatory muscle pain lasting for over 3 months.
Treatment:
Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination
Diagnostic Test: Blood test
Control group
Description:
Participants without masticatory muscle pain in last 6 months.
Treatment:
Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination
Diagnostic Test: Blood test

Trial contacts and locations

1

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Central trial contact

Mieszko Więckiewicz, Professor; Piotr Seweryn, Master

Data sourced from clinicaltrials.gov

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