Temporomandibular Joint DisordersNCT06222736
Evaluation of the Efficacy of Cervical Core Exercises in Persons With Temporomandibular Joint Dysfunction
A study testing Rocabado Exercises and Servical Core Exercises in people with Temporomandibular Joint Disorders, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Rocabado Exercises and Servical Core Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 15 Nov 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with Temporomandibular Disorder caused by Myofascial Pain Syndrome
- Female gender aged 18 and over
- Volunteering to participate in the study
- Not having communication difficulties such as speaking and understanding Turkish or not being able to understand the exercises.
Who cannot join
- Having a history of acute trauma in and around the Temporomandibular Joint
- Having Temporomandibular Joint dysfunction due to neurological disease
- Having a history of surgical/invasive procedures or treatments on the Temporomandibular Joint
- Presence of infection or tumoral structure within intraoral structures
- Having a history of tooth loss or prosthetic tooth use
- Having a history of surgical procedure in the cervical area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Gelisim University
Istanbul, Avcılar
Tuğçe Bilgic, Msc, 05065098527, tuyilmaz@gelisim.edu.tr
About this study
The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people.Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks.
Read the detailed description
The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people with the "Research Randomizer" program. Randomization, evaluation and treatment of the groups will be done by different researchers.
Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks. Evaluation will be made at the beginning and at the eight week to see the short-term effects. Rocabado exercises will be given to the first group, Cervical Core exercises will be given to the second group, and Rocabado and Cervical Core exercises will be given together to the third group. After the initial evaluations, all exercises will be taught to the patients in the first week, they will be planned as home exercises in the following weeks, and online follow-up will be done via tele-rehabilitation.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Rocabado Exercises, Servical Core Exercises
- Keywords
- Temporomandibular Joint, servical core exercise, myofasial 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.
Rocabado ExercisesOther
Patients trained by Rocabado Exercises
Servical Core ExercisesOther
Servical Core Exercises
| Study group | Role | What they receive |
|---|---|---|
| Rocabado exercises group | Experimental | The most commonly known form of exercise for Temporomandibular Disfunction is Rocabado exercises, which use 6 types of exercises 6 times a day. Receives: Other: Rocabado Exercises |
| Servical Core Exercises Group | Experimental | The purpose of core exercises is to support the vertebral column, especially by activating the stabilizing muscles, and to develop and maintain proper cervical posture by increasing kinesthetic awareness. At the beginning of the exercises, the patient is taught to contract the deep stabilizer muscles in a controlled manner, in isolation, without contraction of the superficial muscles. Exercises 2 days a week for 8 weeks, maximum 30 minutes. The session will be actively applied by the patient for a period of time. Receives: Other: Servical Core Exercises |
| Rocabado Exercises and Servical Core Exercises Group | Experimental | The most commonly known form of exercise for Temporomandibular Disfunction is Rocabado exercises, which use 6 types of exercises 6 times a day. The purpose of Servical Core exercises is to support the vertebral column, especially by activating the stabilizing muscles, and to develop and maintain proper cervical posture by increasing kinesthetic awareness. At the beginning of the exercises, the patient is taught to contract the deep stabilizer muscles in a controlled manner, in isolation, without contraction of the superficial muscles. Exercises 2 days a week for 8 weeks, maximum 30 minutes. The session will be actively applied by the patient for a period of time. Receives: Other: Rocabado Exercises; Other: Servical Core Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The severity of pain felt by individuals in the Temporomandibular Joint and Cervical Region, at rest, during activity and at night, will be evaluated numerically using the visual analog scale. Individuals will be told that the number "0" on a 10 cm horizontal line indicates "no pain" and the number "10" indicates "unbearable pain". The location marked by the individual will be determined as the pain intensity in cm.
Measured: 8 weeks
Algometer
Algometer will be used for objective measurement of Pain Threshold Assessment. The pressure will be applied to the massater, temporalis and upper trapezius muscles bilaterally, increasing the pressure by 1kg/cm2 every three seconds until the patient feels pain. The subject is told to report when he/she feels pain while applying force (kg/cm²) with the device. This process is repeated three times to calculate the average value on the muscles.
Measured: 8 weeks
Mandibular Range of Motion
Mandibular Range of Motion, Pain-free mouth opening, maximum mouth opening, maximum assisted mouth opening, right lateral and left lateral movements will be evaluated by the physiotherapist with the help of a ruler
Measured: 8 weeks
Jaw Functionality Assessment
'Functional Limitation Scale of the Jaw-8' will be used for functionality evaluation. The individual is asked to determine the level of restriction for each of the 8 items on the scale in the last month. Individuals are told that the number '0' on a 10cm horizontal line indicates 'no restriction' and the number '10' indicates 'severe restriction'. Functionality limitation is calculated by taking the average of the individual's answers.
Measured: 8 weeks
craniovertebral angle
An objective method of assessing cervical anterior tilt is to measure the craniovertebral angle. Head position is expressed in degrees (°) by measuring the angle between the horizontal plane and the seventh cervical vertebra (C7) and the ear with a goniometer. Measurements are taken while individuals sit in a comfortable position with their arms at their sides and their backs supported on a chair. C7 is detected by manual palpation. While one of the goniometric arms extends to the ear (external auditory canal), the other arm is kept parallel to the horizontal plane. C7, the angle between the ear and the horizontal plane is recorded in degrees
Measured: 8 weeks
Cervical Range of Motion
The cervical region will be evaluated with the active Cervical Range of Motion device. The device consists of inclinometers placed on the left lateral side of the head, in the middle of the forehead and on the head, and a magnetic collar placed on the neck. All measurements will be made while patients are sitting in an upright position on a chair with their arms adjacent to the body.
Measured: 8 weeks
Cervical region deep flexor muscle endurance
To evaluate deep flexor muscle endurance in the cervical region, the patient is placed on the abdomen with hands free while the patient is in a supine hook position. Isometrically lifts the patient's head 2.5 cm off the ground with the patient's chin at maximum tilt. The maximum time in which the patient raises his head and maintains this position is recorded in seconds. The test is terminated when the patient feels pain and cannot maintain the position.
Measured: 8 weeks
Secondary outcomes (2)
Neck Disability Assessment
The Neck Disability Index is a tool used to determine how the pain participants feel in their neck affects their daily lives. In the 10-question survey, A = 0 points, B = 1 point, C = 2 points, D = 3 points, E = 4 points, F = 5 points are given for each question and the total score is obtained. According to the test scoring, 0-4=No disability, 5-14=Mild disability, 15-24=Moderate disability, 25-34=Severe disability, 35 or above=Complete disability.
Measured: 8 weeks
Psychiatric Evaluation
Hospital Anxiety and Depression Scale is used to determine individuals' depression and anxiety levels. The scale consists of two subscales, seven measuring anxiety and seven measuring depression (odd numbers are anxiety, even numbers are depression), and a total of 14 items. Each item is scored on a 4-point Likert scale between 0 and 3. According to the scores obtained from the scales, the anxiety and depression status of individuals is evaluated as not being sick (0-7 points), borderline sick (8-10 points), and significantly sick (11-21). Considering the cut-off scores in Turkey, which are affected by the cultural situation in the country, individuals who score 10 points or more from the anxiety subscale and individuals who score above 7 points from the depression subscale are defined as risky.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Oct 2023
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study will be conducted at the Istanbul University-Çapa Faculty of Dentistry Total and Partial Prosthesis clinic with volunteers who have been diagnosed with Temporomandibular disfunction.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Bilgiç, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222736
- Sponsor's protocol ID
- IstanbulGelisimU
- Status last verified
- Nov 2024
- First submitted
- 9 Jan 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Cervical Core Exercises in Persons With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06222736
- Acronym / sponsor ID
- IstanbulGelisimU
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Temporomandibular Joint, servical core exercise, myofasial pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 25 Jan 2024 (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 is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people.Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks.
Detailed description
The aim is to reveal to what extent cervical core exercises affect the results of treatment in patients with Temporomandibular Joint Dysfunction caused by Myofascial pain syndrome. Randomization will be carried out by dividing individuals who agree to participate in the study into 3 groups of 20 people with the "Research Randomizer" program. Randomization, evaluation and treatment of the groups will be done by different researchers.
Participants will be divided into three groups, and all three groups will receive treatment in 30-45 minute sessions a day, 2 days a week for 8 weeks. Evaluation will be made at the beginning and at the eight week to see the short-term effects. Rocabado exercises will be given to the first group, Cervical Core exercises will be given to the second group, and Rocabado and Cervical Core exercises will be given together to the third group. After the initial evaluations, all exercises will be taught to the patients in the first week, they will be planned as home exercises in the following weeks, and online follow-up will be done via tele-rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Our study will be conducted at the Istanbul University-Çapa Faculty of Dentistry Total and Partial Prosthesis clinic with volunteers who have been diagnosed with Temporomandibular disfunction.
| Arm | Type | Receives |
|---|---|---|
| Rocabado exercises group | Experimental | Other: Rocabado ExercisesThe most commonly known form of exercise for Temporomandibular Disfunction is Rocabado exercises, which use 6 types of exercises 6 times a day. |
| Servical Core Exercises Group | Experimental | Other: Servical Core ExercisesThe purpose of core exercises is to support the vertebral column, especially by activating the stabilizing muscles, and to develop and maintain proper cervical posture by increasing kinesthetic awareness. At the beginning of the exercises, the patient is taught to contract the deep stabilizer muscles in a controlled manner, in isolation, without contraction of the superficial muscles. Exercises 2 days a week for 8 weeks, maximum 30 minutes. The session will be actively applied by the patient for a period of time. |
| Rocabado Exercises and Servical Core Exercises Group | Experimental | Other: Rocabado Exercises, Other: Servical Core ExercisesThe most commonly known form of exercise for Temporomandibular Disfunction is Rocabado exercises, which use 6 types of exercises 6 times a day. The purpose of Servical Core exercises is to support the vertebral column, especially by activating the stabilizing muscles, and to develop and maintain proper cervical posture by increasing kinesthetic awareness. At the beginning of the exercises, the patient is taught to contract the deep stabilizer muscles in a controlled manner, in isolation, without contraction of the superficial muscles. Exercises 2 days a week for 8 weeks, maximum 30 minutes. The session will be actively applied by the patient for a period of time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with Temporomandibular Disorder caused by Myofascial Pain Syndrome
- Female gender aged 18 and over
- Volunteering to participate in the study
- Not having communication difficulties such as speaking and understanding Turkish or not being able to understand the exercises.
Key exclusion criteria (6 listed)
- Having a history of acute trauma in and around the Temporomandibular Joint
- Having Temporomandibular Joint dysfunction due to neurological disease
- Having a history of surgical/invasive procedures or treatments on the Temporomandibular Joint
- Presence of infection or tumoral structure within intraoral structures
- Having a history of tooth loss or prosthetic tooth use
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 |
|---|---|---|
| Rocabado ExercisesPatients trained by Rocabado Exercises | Other | Rocabado Exercises and Servical Core Exercises Group, Rocabado exercises group |
| Servical Core ExercisesServical Core Exercises | Other | Rocabado Exercises and Servical Core Exercises Group, Servical Core Exercises Group |
Primary outcome
Visual Analogue Scale
Time frame: 8 weeks
The severity of pain felt by individuals in the Temporomandibular Joint and Cervical Region, at rest, during activity and at night, will be evaluated numerically using the visual analog scale. Individuals will be told that the number "0" on a 10 cm horizontal line indicates "no pain" and the number "10" indicates "unbearable pain". The location marked by the individual will be determined as the pain intensity in cm.
Algometer
Time frame: 8 weeks
Algometer will be used for objective measurement of Pain Threshold Assessment. The pressure will be applied to the massater, temporalis and upper trapezius muscles bilaterally, increasing the pressure by 1kg/cm2 every three seconds until the patient feels pain. The subject is told to report when he/she feels pain while applying force (kg/cm²) with the device. This process is repeated three times to calculate the average value on the muscles.
Mandibular Range of Motion
Time frame: 8 weeks
Mandibular Range of Motion, Pain-free mouth opening, maximum mouth opening, maximum assisted mouth opening, right lateral and left lateral movements will be evaluated by the physiotherapist with the help of a ruler
Jaw Functionality Assessment
Time frame: 8 weeks
'Functional Limitation Scale of the Jaw-8' will be used for functionality evaluation. The individual is asked to determine the level of restriction for each of the 8 items on the scale in the last month. Individuals are told that the number '0' on a 10cm horizontal line indicates 'no restriction' and the number '10' indicates 'severe restriction'. Functionality limitation is calculated by taking the average of the individual's answers.
craniovertebral angle
Time frame: 8 weeks
An objective method of assessing cervical anterior tilt is to measure the craniovertebral angle. Head position is expressed in degrees (°) by measuring the angle between the horizontal plane and the seventh cervical vertebra (C7) and the ear with a goniometer. Measurements are taken while individuals sit in a comfortable position with their arms at their sides and their backs supported on a chair. C7 is detected by manual palpation. While one of the goniometric arms extends to the ear (external auditory canal), the other arm is kept parallel to the horizontal plane. C7, the angle between the ear and the horizontal plane is recorded in degrees
Cervical Range of Motion
Time frame: 8 weeks
The cervical region will be evaluated with the active Cervical Range of Motion device. The device consists of inclinometers placed on the left lateral side of the head, in the middle of the forehead and on the head, and a magnetic collar placed on the neck. All measurements will be made while patients are sitting in an upright position on a chair with their arms adjacent to the body.
Cervical region deep flexor muscle endurance
Time frame: 8 weeks
To evaluate deep flexor muscle endurance in the cervical region, the patient is placed on the abdomen with hands free while the patient is in a supine hook position. Isometrically lifts the patient's head 2.5 cm off the ground with the patient's chin at maximum tilt. The maximum time in which the patient raises his head and maintains this position is recorded in seconds. The test is terminated when the patient feels pain and cannot maintain the position.
2 secondary outcomes
Neck Disability Assessment
Time frame: 8 weeks
Psychiatric Evaluation
Time frame: 8 weeks
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 19 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabado Exercises and Servical Core Exercises in people with Temporomandibular Joint Disorders, run by Istanbul Gelisim 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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?
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?
Contact Tuğçe Bilgic, Msc (05065098527, tuyilmaz@gelisim.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 8 weeks). The study lists 7 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 19 Nov 2024.