Temporomandibular Joint DisordersNCT05740826
Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Joint Disorders, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
This study evaluated the correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction Read more about this study
- Who is it for?
- Ages 19 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Algometer
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 8 Sep 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Students from Poland
Who may be able to join
- age 19-25 years
- relatively good health
- consent to participate in the research experiment
Who cannot join
- people with skin problems in the head and neck area that that made the examination impossible
- previous head and neck surgeries and traffic injuries
- coagulation disorders or taking medications that reduce blood coagulability
- venous thrombosis in the neck area
- sensory disorders
- dislocation of the jaw in the past
- taking painkillers 12 hours before starting the study
- being under orthodontic or physiotherapeutic treatment focused on TMJ dysfunctions
Trial locations and contacts
1 site in 1 country.
Poland1 site
Clinic for Rehabilitation
Poznan, Greater Poland Voivodeship, 61-545
About this study
This study evaluated the correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction
Read the detailed description
The examination includes personal questionnaire, physical examination and an algometer measurement on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and rectus capitis posterior major to define pressure sensitivity of neck muscles and define is there a correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Algometer
- Keywords
- TMJ disorders, pressure sensitivity, algometer, young adults, myofascial pain
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgometerDevice
The algometer head was applied to the trigger point of selected muscles at an angle of 90° and, increasing the pressure at a speed of about 100g/s, three measurements were made. Each measurement stoped at the first sensation of pain
| Study group | Role | What they receive |
|---|---|---|
| Study group | People with temporomandibular disorder which was determined based on one of the following factors observed during the examination: acoustic symptoms, present temporomandibular joint pain, problems with opening the mouth, deviation of the jaw during abduction, or reported locking of the jaw. Receives: Device: Algometer | |
| Control group | People without temporomandibular disorder. Receives: Device: Algometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure sensitivity
Algometer measurements on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and rectus capitis posterior major
Measured: for each participant duration of test is about 30-40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start8 Sep 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jagoda Goślińska, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740826
- Sponsor's protocol ID
- 676/22
- Status last verified
- Feb 2023
- First submitted
- 10 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sensitive data, maybe available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cervical Spine Muscle Disorders and the Occurrence of Symptoms of Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05740826
- Acronym / sponsor ID
- 676/22
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- TMJ disorders, pressure sensitivity, algometer, young adults, myofascial pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 23 Feb 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.
This study evaluated the correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction
Detailed description
The examination includes personal questionnaire, physical examination and an algometer measurement on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and rectus capitis posterior major to define pressure sensitivity of neck muscles and define is there a correlation between the occurrence of disorders of selected muscles of the cervical spine and the occurrence of symptoms of TMJ dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: AlgometerPeople with temporomandibular disorder which was determined based on one of the following factors observed during the examination: acoustic symptoms, present temporomandibular joint pain, problems with opening the mouth, deviation of the jaw during abduction, or reported locking of the jaw. |
| Control group | – | Device: AlgometerPeople without temporomandibular disorder. |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Students from Poland
Key inclusion criteria (3 listed)
- age 19-25 years
- relatively good health
- consent to participate in the research experiment
Key exclusion criteria (8 listed)
- people with skin problems in the head and neck area that that made the examination impossible
- previous head and neck surgeries and traffic injuries
- coagulation disorders or taking medications that reduce blood coagulability
- venous thrombosis in the neck area
- sensory disorders
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 |
|---|---|---|
| AlgometerThe algometer head was applied to the trigger point of selected muscles at an angle of 90° and, increasing the pressure at a speed of about 100g/s, three measurements were made. Each measurement stoped at the first sensation of pain | Device | Control group, Study group |
Primary outcome
Pressure sensitivity
Time frame: for each participant duration of test is about 30-40 minutes
Algometer measurements on the upper fibers of the trapezius, levator scapula, sternocleidomastoid and rectus capitis posterior major
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Undecided. Sensitive data, maybe available on reasonable request
Related trials for Temporomandibular Joint Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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. This study is not recruiting at the moment.
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 Temporomandibular Joint Disorders, run by Poznan University of Medical Sciences 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 23 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pressure sensitivity (time frame: for each participant duration of test is about 30-40 minutes). 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 23 Feb 2023.