Temporomandibular DisordersNCT04982601
Yoga-Based Exercise Program For Temporomandibular Disorders
A study testing Yoga Exercises in people with Temporomandibular Disorders and Myofascial Pain Dysfunction Syndrome, run by Medipol University.
Trial summary
Aims:The study was conducted to investigate the effect of Yoga-based exercise program on pain, range of motion(ROM), sleep quality, depression and quality of life in female patients with myofascial pain dysfunction(MPD) of temporomandibular disorders . Methods: MPD will be included in the study. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Temporomandibular Disorders, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Pain
- What is being tested?
- Yoga Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2014to 7 Jun 2020
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 20-50 years diagnosed with MPD(myofascial pain dysfunction) syndrome according to the Research Diagnostic Criteria For Temporomandibular Disorders
Who cannot join
- Those with orthopedic problems such as degenerative arthritis and traumatic injuries, took physiotherapy program in the last 3 months and drug users were not included in the study.
About this study
Official title: Evaluation of Yoga-Based Exercise Program for Females With Temporomandibular Disorders: A Randomized Clinical Trial
Aims:The study was conducted to investigate the effect of Yoga-based exercise program on pain, range of motion(ROM), sleep quality, depression and quality of life in female patients with myofascial pain dysfunction(MPD) of temporomandibular disorders .
Methods: MPD will be included in the study. Yoga based exercise program will be performed to the first group as 3 times in a week for 6 weeks. The second group will be the control group. Outcome measurements; pain ,sleep quality, depression and quality of life will be evaluated. Evaluations will be repeated before and 6 weeks after exercise.
Read the detailed description
Total 46 female patients between the ages of 20-50 planned to include in the study. In the study, 42 volunteers divided into two groups as yoga group (Group 1) and control group (Group 2). As a result of randomization, those chose 1 were taken in group 1, 2 were included in group 2. Yoga-based exercises performs for 6 weeks and 3 days in a week for the first group. The second group will be taken in the waiting list to be included in the program as a control group.
Yoga-based exercises perform by a physiotherapist has Yoga training, by consisting of 10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises and lasts about one hour.
Before the treatment, evaluations made immediately after the 6-weeks exercise program ended. As the primary outcome measures; jaw pain Visual Analog Scale (VAS), Neck Pain And Disability Scale (NPDS), neck and jaw range of motion (ROM) measurements; for secondary outcome measurements; the Pittsburg Sleep Quality Index (PUQI), Beck Depression Inventory (BDI) and Short Form 36 (SF36) are used. All measurements are repeated at the 6th week after yoga application and datas compared with the baseline measurements.
- Conditions
- Temporomandibular Disorders, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Pain, Range of Motion, Yoga, Quality of Life
- Being tested
- Yoga Exercises
- Medical subject headings
- Temporomandibular Joint Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ExercisesOther
Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Yoga-based exercises were performed by a physiotherapist has Yoga training, by consisting of 10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises and lasts about one hour. Especially combined movements with upper extremity and neck movements and breathing exercises were used in breathing exercises. In the warm-up exercises, the muscles were extended by giving exercises especially for stretching the muscles. In this way, asanas were prepared. Asanas Ardra kati cahkrasana, padahastasana, trikosana, sasankasana, varaksana poses have been performed. Asanas were modified and applied according to the patient's condition. Relaxation exercises were used both after breathing exercises and at the end of the exercise program. With relaxation, the patients were allowed to leave their muscles relaxed with the whole body relaxation Receives: Other: Yoga Exercises |
| Control Group | No intervention | No kind of intervention has been applied to control group they awaited for therapy procedure for 6 week. They have assessed at the end of the 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale(VAS)
Pain intensity felt in the chin was evaluated with VAS at rest. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
Measured: 6 weeks
Neck Pain And Disability Scale (NPDS)
It is examined with Neck Pain and Disability Scale (NPDS). The severity of neck pain, duration of symptoms, and the disability of each item in the specified activities are evaluated. Each item is scored between 0-5 points. The total score is the sum of the points in each item and ranges from 0 to 100. High scores indicate more severe pain and effect
Measured: 6 weeks
Neck and jaw range of motion (ROM)
The neck and chin area of the patients were measured with a ROM universal goniometer. While neck normal joint motion flexion (0-65 °), extension (50 °), lateral flexion (45 °) and rotation (60-80 °) were measured, TMJ movements, mandibular depression, protrusion, deviation movements were measured. Measurements were taken 3 times and the mean value was recorded
Measured: 6 weeks
Secondary outcomes (3)
Pittsburg Sleep Quality Index (PUQI)
Pittsburg Sleep Quality Index (PSQI) is a questionnaire that evaluates sleep quality with questions asked in 7 main topics as: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficacy, sleep disorders, use of sleep medication and daytime functions. Questions are given a score between 0-3, high scores reflect poor sleep quality. Each of the seven main titles is evaluated first in itself. The scores of these components are added. Maximum 21 points are taken in total, and 5 points and above are considered as poor sleep quality
Measured: 6 weeks
Beck Depression Inventory (BDI)
The depression level of the cases was evaluated using the Turkish version of the Beck Depression Inventory (BDI). Each of the items of the questionnaire examines somatic, affective and cognitive symptoms. Each item consists of 4 separate sentences that composed as showing increased severtiy about a specific symptom of depression. The sentences are scored between zero and three to indicate the severity of depression. High scores indicate more severe depression. The highest score that can be obtained in the survey is 63. For evaluation; 0-14 points shows mild depression, 15-29 points shows moderate depression, 30-63 points shows a serious depression level
Measured: 6 weeks
Short Form 36 (SF36)
Turkish version of Short Form 36 (SF-36) was used to evaluate the quality of life. The SF-36 questionnaire with 36 items that measure eight health related quality of life domains: physical functioning (PF), social functioning (SF), role limitation due to physical problems (RP), role limitation due to emotional problems (RE), mental health (MH), energy and vitality (VT), bodily pain (BP), and general perception of health (GH). In the calculation of the results, each subscale is calculated separately. The scores of the subscales vary between 0 and 100, and the high score indicates good health
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start7 Jan 2014
- Primary completion7 Jun 2019
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA ATILGAN, Medipol University
- Investigators
- ESRA ATILGAN, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982601
- Sponsor's protocol ID
- 10840098-07
- Status last verified
- Jul 2021
- First submitted
- 8 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atilgan E, Kurt H, Algun ZC. Effect of yoga-based exercise program in female patients with myofacial pain of temporomandibular disorders. Clin Oral Investig. 2024 Nov 16;28(12):642. doi: 10.1007/s00784-024-06045-y.
PubMed 39547987
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Yoga-Based Exercise Program for Females With Temporomandibular Disorders: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04982601
- Acronym / sponsor ID
- 10840098-07
- Conditions
- Temporomandibular Disorders, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Pain, Range of Motion, Yoga, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 7 Jan 2014 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 29 Jul 2021 (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.
Aims:The study was conducted to investigate the effect of Yoga-based exercise program on pain, range of motion(ROM), sleep quality, depression and quality of life in female patients with myofascial pain dysfunction(MPD) of temporomandibular disorders .
Methods: MPD will be included in the study. Yoga based exercise program will be performed to the first group as 3 times in a week for 6 weeks. The second group will be the control group. Outcome measurements; pain ,sleep quality, depression and quality of life will be evaluated. Evaluations will be repeated before and 6 weeks after exercise.
Detailed description
Total 46 female patients between the ages of 20-50 planned to include in the study. In the study, 42 volunteers divided into two groups as yoga group (Group 1) and control group (Group 2). As a result of randomization, those chose 1 were taken in group 1, 2 were included in group 2. Yoga-based exercises performs for 6 weeks and 3 days in a week for the first group. The second group will be taken in the waiting list to be included in the program as a control group.
Yoga-based exercises perform by a physiotherapist has Yoga training, by consisting of 10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises and lasts about one hour.
Before the treatment, evaluations made immediately after the 6-weeks exercise program ended. As the primary outcome measures; jaw pain Visual Analog Scale (VAS), Neck Pain And Disability Scale (NPDS), neck and jaw range of motion (ROM) measurements; for secondary outcome measurements; the Pittsburg Sleep Quality Index (PUQI), Beck Depression Inventory (BDI) and Short Form 36 (SF36) are used. All measurements are repeated at the 6th week after yoga application and datas compared with the baseline measurements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Other: Yoga ExercisesYoga-based exercises were performed by a physiotherapist has Yoga training, by consisting of 10-person groups, 6 weeks, 3 days in a week for a total of 18 sessions. Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises and lasts about one hour. Especially combined movements with upper extremity and neck movements and breathing exercises were used in breathing exercises. In the warm-up exercises, the muscles were extended by giving exercises especially for stretching the muscles. In this way, asanas were prepared. Asanas Ardra kati cahkrasana, padahastasana, trikosana, sasankasana, varaksana poses have been performed. Asanas were modified and applied according to the patient's condition. Relaxation exercises were used both after breathing exercises and at the end of the exercise program. With relaxation, the patients were allowed to leave their muscles relaxed with the whole body relaxation |
| Control Group | No intervention | –No kind of intervention has been applied to control group they awaited for therapy procedure for 6 week. They have assessed at the end of the 6 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patients aged 20-50 years diagnosed with MPD(myofascial pain dysfunction) syndrome according to the Research Diagnostic Criteria For Temporomandibular Disorders
Key exclusion criteria (1 listed)
- Those with orthopedic problems such as degenerative arthritis and traumatic injuries, took physiotherapy program in the last 3 months and drug users were not included in the study.
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 |
|---|---|---|
| Yoga ExercisesYoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises. | Other | Yoga Group |
Primary outcome
Visual Analog Scale(VAS)
Time frame: 6 weeks
Pain intensity felt in the chin was evaluated with VAS at rest. They were asked to draw their pain level on a 10 cm scale between 0-10 points as 0=no pain, 10 unbearable pain
Neck Pain And Disability Scale (NPDS)
Time frame: 6 weeks
It is examined with Neck Pain and Disability Scale (NPDS). The severity of neck pain, duration of symptoms, and the disability of each item in the specified activities are evaluated. Each item is scored between 0-5 points. The total score is the sum of the points in each item and ranges from 0 to 100. High scores indicate more severe pain and effect
Neck and jaw range of motion (ROM)
Time frame: 6 weeks
The neck and chin area of the patients were measured with a ROM universal goniometer. While neck normal joint motion flexion (0-65 °), extension (50 °), lateral flexion (45 °) and rotation (60-80 °) were measured, TMJ movements, mandibular depression, protrusion, deviation movements were measured. Measurements were taken 3 times and the mean value was recorded
3 secondary outcomes
Pittsburg Sleep Quality Index (PUQI)
Time frame: 6 weeks
Beck Depression Inventory (BDI)
Time frame: 6 weeks
Short Form 36 (SF36)
Time frame: 6 weeks
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 29 Jul 2021.
- Derived from this study: PubMed 39547987Atilgan E, Kurt H, Algun ZC. Effect of yoga-based exercise program in female patients with myofacial pain of temporomandibular disorders. Clin Oral Investig. 2024 Nov 16;28(12):642. doi: 10.1007/s00784-024-06045-y.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
ESRA ATILGAN, PhD principal investigator
Medipol University
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Exercises in people with Temporomandibular Disorders and Myofascial Pain Dysfunction Syndrome, run by Medipol University.
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 1 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: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Analog Scale(VAS) (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT04982601, which also lists 1 linked publication.
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 29 Jul 2021.