Clinical trial NCT05676827: Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
Official title: Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: TMD
Keywords: TMD, masticatory muscle pain, central sensitization
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of 51 patients with masticatory muscle pain for at least 3 months, diagnosed on basis of DC/TMD protocol

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and serotonin and dopamine levels.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and magnesium, sodium, potasium and calcium levels.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and cortisol level.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and CRP level.
timeFrame: January 3, 2023 - January 3, 2024
Secondary outcomes:
measure: Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and PPTs.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and Type D personality assessed by DS-14 quesstionaire.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and coping with stress assessed by mini COPE.
timeFrame: January 3, 2023 - January 3, 2024
measure: Relationship between masticatory muscle pain and central sensitization assessed by Central Sensitization Inventory.
timeFrame: January 3, 2023 - January 3, 2024
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
References: