Temporomandibular Joint DysfunctionNCT05420896
Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint Dysfunction.
A study testing Manual Therapy in people with Temporomandibular Joint Dysfunction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2021to 10 Nov 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No cognitive impairment
- Diagnosed with temporomandibular joint(TMJ) dysfunction of myofascial origin,
- Volunteers aged 18-65
Who cannot join
- Malignancy and fracture of the cervical region and/or TMJ
- Active infection
- Patients actively receiving cervical and/or TMJ-related therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint
Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD.
Read the detailed description
TMD is a common condition in the community. It may occur due to factors such as trauma, stress, occlusal disorders. Symptoms include pain, limitation in mouth opening, joint voice, postural and psychosocial disorders. TMD/RDC diagnostic criteria are used in the classification of TMD, and accordingly, it is stated that it may originate from the joint, disc and chewing muscles. In the treatment, conservative treatments such as patient education, manual therapy and exercises are applied first.
Manual therapy is an effective physiotherapy method on pain and muscle dysfunctions in musculoskeletal problems. In our study, electromyographic changes of masticatory muscles will be examined by applying manual treatment to the masticatory muscles and cervical region in myofascial TMD patients according to TMD/RC.
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Manual Therapy
- Keywords
- temporomandibular joint dysfunction, manual therapy, EMG, maximal mouth opening
- 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.
Manual TherapyOther
Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Active comparator | Upper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG. Receives: Other: Manual Therapy |
| Control group | No intervention | Patients assigned to the control group randomly will be re-evaluated 4 weeks after their initial evaluation. No intervention will be applied during this period. After 4 weeks, when the patients are re-evaluated, they will be directed to the appropriate treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: Change from initial assessment to 4 weeks after initial assessment.
Secondary outcomes (6)
Electromyography (EMG)
Electromyography (EMG) is the most objective and reliable method available for imaging muscle function and efficiency, which is done by identifying their electrical potentials. In global surface electromyography (sEMG), surface electrodes are located on the surface of the skin, and it detects superimposed motor unit action potentials from many muscle fibers
Measured: Change from initial assessment to 4 weeks after initial assessment.
Pain Pressure Threshold (PPT)
Pain pressure threshold (PPT) is used to measure deep muscular tissue sensitivity. The test determines the amount of pressure over a given area in which a steadily increasing nonpainful pressure stimulus turns into a painful pressure sensation. A varying pressure is applied from 0.5 to 1 kg/sec in a perpendicular direction relative to the muscle.
Measured: Change from initial assessment to 4 weeks after initial assessment.
Maximum Mouth Opening (MMO)
Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite. Clinical measurement of normal range of Maximum Mouth Opening (MMO) is an important diagnostic criterion for evaluation of stomatognathic system, especially for those with temporomandibular dysfunctions.
Measured: Change from initial assessment to 4 weeks after initial assessment.
TAMPA
The original Tampa Scale of Kinesiophobiais (TSK) was first developed in 1991 by R. Miller, S. Kopri, and D. Todd. TSK is 12 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance.
The questionnaire using 4 points to assess that are based on; the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.
Measured: Change from initial assessment to 4 weeks after initial assessment.
Functional Limitation Scale of the Jaw-8
It is a scale used to evaluate the functionality of the individual's jaw joint in the last month. It consists of 8 items, where the number '0' indicates 'no restriction' and the number '10' indicates 'serious restriction'. By taking the average of the answers given, the functionality restriction is calculated.
Measured: Change from initial assessment to 4 weeks after initial assessment.
Hospital Anxiety Depression Scale (HADS)
The Hospital Anxiety Depression Scale (HADS) includes two subscales, seven of which measure anxiety (odd numbers) and seven (even numbers) depression, which are used to determine the depression and anxiety levels of individuals, and a total of 14 questions. Each question is scored between 0-3 points. While the minimum score that can be obtained from the depression and anxiety subscales is 0, the maximum score is 21. According to the scores obtained from the subscales, the depression and anxiety status of the individuals are evaluated as normal/no symptoms (0-7 points), borderline abnormal/suspicious (8-10 points), and abnormal/definite (11-21 points).
Measured: Change from initial assessment to 4 weeks after initial assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start10 Jun 2021
- Primary completion5 Sep 2022
- Study completion10 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kumru Ateş, Bahçeşehir University
- Investigators
- Kumru Ateş, PhC, Principal investigator, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420896
- Sponsor's protocol ID
- BahçesehırÜniversitesi
- Status last verified
- Feb 2023
- First submitted
- 13 Jun 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Evaluation of the Efficacy of Manual Therapy in Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT05420896
- Acronym / sponsor ID
- BahçesehırÜniversitesi
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- temporomandibular joint dysfunction, manual therapy, EMG, maximal mouth opening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 10 Nov 2022 (actual)
- First posted
- 15 Jun 2022 (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.
Individuals with temporomandibular joint dysfunction (TMD) may experience changes in muscle activation as a result of symptoms such as pain and limitation of movement. The aim of this study is to examine the efficacy of manual therapy electromyographically in patients with TMD.
Detailed description
TMD is a common condition in the community. It may occur due to factors such as trauma, stress, occlusal disorders. Symptoms include pain, limitation in mouth opening, joint voice, postural and psychosocial disorders. TMD/RDC diagnostic criteria are used in the classification of TMD, and accordingly, it is stated that it may originate from the joint, disc and chewing muscles. In the treatment, conservative treatments such as patient education, manual therapy and exercises are applied first.
Manual therapy is an effective physiotherapy method on pain and muscle dysfunctions in musculoskeletal problems. In our study, electromyographic changes of masticatory muscles will be examined by applying manual treatment to the masticatory muscles and cervical region in myofascial TMD patients according to TMD/RC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Active comparator | Other: Manual TherapyUpper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG. |
| Control group | No intervention | –Patients assigned to the control group randomly will be re-evaluated 4 weeks after their initial evaluation. No intervention will be applied during this period. After 4 weeks, when the patients are re-evaluated, they will be directed to the appropriate treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No cognitive impairment
- Diagnosed with temporomandibular joint(TMJ) dysfunction of myofascial origin,
- Volunteers aged 18-65
Key exclusion criteria (3 listed)
- Malignancy and fracture of the cervical region and/or TMJ
- Active infection
- Patients actively receiving cervical and/or TMJ-related therapy
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 |
|---|---|---|
| Manual TherapyUpper cervical spine mobilization Posterior-anterior mobilization of the fifth cervical vertebra Suboccipital inhibition Suboccipital mobilization Trigger point application to my masseter, temporal and sternocleidomastoid muscles Intraoral and extraoral myofascial release Intraoral sphenopalatine ganglion technique TMJ mobilization Massage for chewing muscles The 45-minute treatment program, which includes applications including the techniques above, will be applied to the patients randomly assigned to the study group once a week for a total of 4 weeks.The changes in muscle activity of the masseter and anterior temporalis bilaterally will be recorded with EMG. | Other | Manual therapy |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Change from initial assessment to 4 weeks after initial assessment.
A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
6 secondary outcomes
Electromyography (EMG)
Time frame: Change from initial assessment to 4 weeks after initial assessment.
Pain Pressure Threshold (PPT)
Time frame: Change from initial assessment to 4 weeks after initial assessment.
Maximum Mouth Opening (MMO)
Time frame: Change from initial assessment to 4 weeks after initial assessment.
TAMPA
Time frame: Change from initial assessment to 4 weeks after initial assessment.
Functional Limitation Scale of the Jaw-8
Time frame: Change from initial assessment to 4 weeks after initial assessment.
Hospital Anxiety Depression Scale (HADS)
Time frame: Change from initial assessment to 4 weeks after initial assessment.
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 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Joint Dysfunction
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.
Kumru Ateş, PhC principal investigator
Bahçeşehir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Temporomandibular Joint Dysfunction, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 3 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 21 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 Turkey (Türkiye). 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?
Visual Analogue Scale (VAS) (time frame: Change from initial assessment to 4 weeks after initial assessment.). 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 21 Feb 2023.