TMDNCT05676827
Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
An observational study of TMD and Masticatory Muscle Pain, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- TMD, Masticatory Muscle Pain
- What is being tested?
- Diagnostic Criteria for Temporomandibular Disorders Clinical Examination and Blood test
- How many people
- 102 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o
- no pain in masticatory muscles, age of at least 18 y.o Exclusion criteria the same as for study group
Who cannot join
- severe neurological or psychiatric diseases, use of drugs that may affect the neuromuscular system, alcohol or drug addiction, cancer or pregnancy, previous head surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
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.
Read the 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 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.
- Conditions
- TMD, Masticatory Muscle Pain
- Being tested
- Diagnostic Criteria for Temporomandibular Disorders Clinical Examination, Blood test
- Keywords
- TMD, masticatory muscle pain, central sensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Criteria for Temporomandibular Disorders Clinical ExaminationDiagnostic test
Clinical examination made by experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the DC/TMD.
Blood testDiagnostic test
Blood samples will be tested to investigate two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) and levels of 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants with masticatory muscle pain lasting for over 3 months. Receives: Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination; Diagnostic Test: Blood test | |
| Control group | Participants without masticatory muscle pain in last 6 months. Receives: Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination; Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
Each participant will undergo genetical blood test.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and serotonin and dopamine levels.
Each participant will undergo blood test.
Measured: January 3, 2023 - January 3, 2024
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.
Each participant will undergo blood test.
Measured: January 3, 2023 - January 3, 2024
Secondary outcomes (8)
Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.
Each participant will fill in Patient Health Questionnaire - 9. PHQ-9 total score for the nine items ranges from 0 to 27.Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and PPTs.
Participants from study group will be tested using algometer to determine pressure pain threshold in masseter muscle and temporal muscle.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.
Each participant will fill in Generalized Anxiety Disorder -7 that consists of 7 items. Total score ranges 0-21 points. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.
Each participant will fill in Perceived Stress Scale -10. Scores are obtained by reversing the scores on the four positive items, e.g., 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4,5, 7, and 8 are the positively stated items. It can range from 0 to 40. Scores ranging from 0-13 would be considered low stress,14-26 would be considered moderate stress, 27-40 would be considered high perceived stress.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.
Each participant will fill in Satisfaction With Life Scale which consist of five questions with 5 possible answers. Total score range is 35. Higher score represents higher life satisfaction. Score ranging from 5-9 as considered as extremly dissatisfied with life, 10-14 dissatisfied, 15-19 slightly dissatisfied, 20-24 slightly satisfied, 25-29 satisfied, 30-35 extremely satisfied.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and Type D personality assessed by DS-14 quesstionaire.
Each participant will fill DS-14 questionnaire which contains 14 Likert-style questions. Each questions has a score range of 0-4. This questionnaire consist of two subscales: negative affectivity and Social Inibition. A cut-off of 10 on both scales is used to classify subject as type-D personality. Maximum score in both scales is 28.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and coping with stress assessed by mini COPE.
Each participant will fill in mini COPE. Questionnaire consists of 28 statements that make up 14 stress coping strategies.Some testing strategies were divided into four categories and corresponding strategies (inventory scales): active coping (including: active coping, planning, positive reevaluation), helplessness (including: taking psychoactive substances, cessation of actions, blaming self), seeking support (including: seeking emotional support, seeking instrumental support), avoidance behaviors (including dealing with something else, denying, discharging). three strategies create independent factors (turning to religion, acceptance, sense of humor). The range of results for each statement ranges from 0 to 3 points. The calculation of the results consists in adding to each other points for the answers regarding two theorems that make up the given scale, and then dividing by 2.
Measured: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and central sensitization assessed by Central Sensitization Inventory.
Each participant will fill in Central Sensitizatin Inventory. This questionnaire consist of two parts. First part includes 25 questions regarding common central sensitivity symptoms. It allows to categorize participant into one of five categories: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), and extreme (60-100) Second part is not scored, but it determines if the participant has been diagnosed with certain CSS disorders or related disorders.
Measured: January 3, 2023 - January 3, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Smardz, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676827
- Sponsor's protocol ID
- WMU1/2022
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Pain, Central Sensitization and Psychoemotional State in Patients With Chronic Masticatory Muscle Pain
- ClinicalTrials.gov ID
- NCT05676827
- Acronym / sponsor ID
- WMU1/2022
- Conditions
- TMD, Masticatory Muscle Pain
- Keywords
- TMD, masticatory muscle pain, central sensitization
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination, Diagnostic Test: Blood testParticipants with masticatory muscle pain lasting for over 3 months. |
| Control group | – | Diagnostic Test: Diagnostic Criteria for Temporomandibular Disorders Clinical Examination, Diagnostic Test: Blood testParticipants without masticatory muscle pain in last 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Masticatory muscle pain for at least 3 months, based on DC/TMD, at least 18 y.o
- no pain in masticatory muscles, age of at least 18 y.o Exclusion criteria the same as for study group
Key exclusion criteria (1 listed)
- severe neurological or psychiatric diseases, use of drugs that may affect the neuromuscular system, alcohol or drug addiction, cancer or pregnancy, previous head surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Criteria for Temporomandibular Disorders Clinical ExaminationClinical examination made by experienced dentists (minimum 5 years of practice) and trained and calibrated in accordance with the protocol available on the DC/TMD. | Diagnostic test | Control group, Study group |
| Blood testBlood samples will be tested to investigate two polymorphisms of genes encoding proteins for serotonin receptors HTR2A - rs4941573 in intron 3 and dopamine DRD3 - rs6280 (Ser9Gly) and levels of 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. | Diagnostic test | Control group, Study group |
Primary outcome
Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280
Time frame: January 3, 2023 - January 3, 2024
Each participant will undergo genetical blood test.
Relationship between masticatory muscle pain and serotonin and dopamine levels.
Time frame: 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.
Time frame: January 3, 2023 - January 3, 2024
Each participant will undergo blood test.
8 secondary outcomes
Relationship between masticatory muscle pain and depression assessed by Patient Health Questionnaire.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and PPTs.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and anxiety assessed by Generalized Anxiety Disorder -7.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and perceived stress assessed by Perceived Stress Scale.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and satisfaction with life assessed by Satisfaction With Life Scale.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and Type D personality assessed by DS-14 quesstionaire.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and coping with stress assessed by mini COPE.
Time frame: January 3, 2023 - January 3, 2024
Relationship between masticatory muscle pain and central sensitization assessed by Central Sensitization Inventory.
Time frame: January 3, 2023 - January 3, 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TMD and Masticatory Muscle Pain, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between masticatory muscle pain and polimorphism of serotonin receptor gene HTR2A - rs4941573 and dopamine receptor gene DRD3 - rs6280 (time frame: January 3, 2023 - January 3, 2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.