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Yoga-Based Exercise Program For Temporomandibular Disorders

Primary Purpose

Temporomandibular Disorders, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga Exercises
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Temporomandibular Disorders

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female patients aged 20-50 years diagnosed with MPD(myofascial pain dysfunction) syndrome according to the Research Diagnostic Criteria For Temporomandibular Disorders

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Yoga Group

    Control Group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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

    Secondary Outcome Measures

    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
    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
    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

    Full Information

    First Posted
    July 8, 2021
    Last Updated
    July 28, 2021
    Sponsor
    Medipol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04982601
    Brief Title
    Yoga-Based Exercise Program For Temporomandibular Disorders
    Official Title
    Evaluation of Yoga-Based Exercise Program for Females With Temporomandibular Disorders: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 7, 2014 (Actual)
    Primary Completion Date
    June 7, 2019 (Actual)
    Study Completion Date
    June 7, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medipol University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorders, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint Pain, Range of Motion, Yoga, Quality of Life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga Group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Yoga Exercises
    Intervention Description
    Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale(VAS)
    Description
    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
    Time Frame
    6 weeks
    Title
    Neck Pain And Disability Scale (NPDS)
    Description
    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
    Time Frame
    6 weeks
    Title
    Neck and jaw range of motion (ROM)
    Description
    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
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Pittsburg Sleep Quality Index (PUQI)
    Description
    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
    Time Frame
    6 weeks
    Title
    Beck Depression Inventory (BDI)
    Description
    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
    Time Frame
    6 weeks
    Title
    Short Form 36 (SF36)
    Description
    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
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    TMD has been reported that it is more common in women than men, as 5 times.
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female patients aged 20-50 years diagnosed with MPD(myofascial pain dysfunction) syndrome according to the Research Diagnostic Criteria For Temporomandibular Disorders Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ESRA ATILGAN, PhD
    Organizational Affiliation
    Medipol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Yoga-Based Exercise Program For Temporomandibular Disorders

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