Back to resultsTelerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism
Primary Purpose
Myofascial Pain, Temporomandibular Disorder, Bruxism
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Home Exercise Group
Telerehabilitation Group
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain focused on measuring Myofascial Pain, Temporomandibular Disorder, Bruxism, Telerehabilitation
Eligibility Criteria
Inclusion Criteria:
- Ages between 18 and 65 years old
- Patients with TMD in the myofascial Group Ia, Ib according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and diagnosed with bruxism
- Having pain ≥ 3 according to the Visual Analog Scale
- Those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study.
Exclusion Criteria:
- Ages under 18 and over 65 years old
- Patients with disc displacement and/or TMJ degeneration
- Patients who have orthodontic or splint treatment
- Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (TMJ) problem malignancy, fracture, the rheumatoid disease is proven
- Patients who have undergone any surgery related to the cervical and/or TMJ
- Patients with facial paralysis
- Patients who regularly use analgesic or anti-inflammatory drugs
- Patients who have received physical therapy associated with TMJ in less than 3 months
- Patients with a history of trauma (whiplash injury, condylar trauma, fracture)
- Patients with cognitive deficits
- Participation rate lower than 80% of the program schedule
Sites / Locations
- Hasan Kalyoncu UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Home Exercise Group
Telerehabilitation Group
Arm Description
The home Exercise program includes an educational training program about parafunctional activities of patients having bruxism with myofascial temporomandibular disorders. The program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises. Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.
The program includes the same stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week. Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.
Outcomes
Primary Outcome Measures
Change from Baseline in Pain at 4 weeks and 8 weeks
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 4 weeks intervention and at the end 8 weeks from baseline.
Change from Baseline in Mandibular range of movements at 4 weeks and 8 weeks
Maximum mouth opening, mandibular lateral right and left shift, and mandibular protrusion range of motion measurements in mm.
Change from Baseline in Neck disability at 4 weeks and 8 weeks
Neck Disability Index, consisting of a total of ten titles, was developed by Vernon and Mior in 1991. It includes topics such as pain intensity in the neck, personal care, lifting, reading, headaches, concentration, driving, sleep, and leisure activities. The maximum score is 50, while the minimum is 0 points.
Classification according to total score is as follows: 0-4 (no restrictions); 5-14 (mild restriction); 15-24 (moderate restriction); 25-34 (severe limitation); 34 and above (completely limited).
Change from Baseline in Headache at 4 weeks and 8 weeks
Headache Impact Test-6 test consists of 6 questions about the severity of headache, the effect of pain on daily life activities, how often it causes fatigue and low motivation, and concentration impairment. Scoring is done between 36-78.
Change from Baseline in Sleep Quality at 4 weeks and 8 weeks
Pittsburg Sleep Quality Index test is used to evaluate sleep effects in the last few months. This questionnaire contains 24 questions, 19 of which are personal, and 5 of which are to be answered by a partner about sleep during both day and night. Five questions answered by the partner are not included in the scoring. Self-assessment questions contain different items related to sleep quality, which provide information about sleep duration, latency, and the frequency and severity of specific sleep problems. The total score is between 0-21. A score of 5 and below indicates good sleep quality, and a score above 5 indicates poor sleep quality.
Change from Baseline in Oral Behavior at 4 weeks and 8 weeks
Evaluation of oral habits with the Oral Habits Questionnaire consisting of 21 items, each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; 1 = several times or 0 = none". The questions cover the times of sleep and wakefulness. The overall score ranges from 0 to 84.
Change from Baseline in Quality of life at 4 weeks and 8 weeks
The individual's personal perception of how oral health affects their quality of life and general health is measured. Oral Health Impact Profile-14 is a scale system that evaluates this perception with questions for functional limitation, physical pain, psychological discomfort, physical, psychological and social inadequacy, and disability measures. It is concluded that as the total score increases, the severity of the problem increases, and the quality of life decreases.
Secondary Outcome Measures
Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks
Forward Head Posture: The angle between the C7-Ear-Horizontal plane in the sitting position (in degrees with a goniometer) Shoulder Posture: The angle between the Acromion-C7-Horizontal Plane in the sitting position (in degrees with a goniometer).
Change from Baseline in Anxiety at 4 weeks and 8 weeks
The State-Trait Anxiety Inventory was developed by Spielberger et al. to measure state anxiety and trait anxiety. The questionnaire consists of 40 questions, the expressions used by the person in expressing his own feelings were included. There are four categories (nothing-a little-much-completely) for answers.
Change from Baseline in Fatigue at 4 weeks and 8 weeks
The Fatigue Severity Scale is used to measure the severity of fatigue in the past week, including today. The questionnaire consists of 9 items in total, and participants are asked to give a score from 1 to 7 for each question. The fatigue level of the patient is determined according to the score obtained by the sum of the points. The higher the level of fatigue, the higher the total score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04884152
Brief Title
Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism
Official Title
Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to compare the effects of Home Exercise Therapy (HET) and Telerehabilitation in patients with myofascial temporomandibular disorders (TMD)with bruxism.
Detailed Description
Home Exercise will be Group 1 and Telerehabilitation group will be Group 2.
Group 1 HET, will include an educational training program about parafunctional activities of TMD disorders and bruxism and active exercises for 4 weeks.
As part of the Home exercise program, a written document will be prepared, including relaxation, breathing training, posture, stretching, and strengthening exercises to be given to the patients.
Group 2, in addition to the training and written document, the second group will receive the same exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain, Temporomandibular Disorder, Bruxism
Keywords
Myofascial Pain, Temporomandibular Disorder, Bruxism, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home Exercise Group
Arm Type
Active Comparator
Arm Description
The home Exercise program includes an educational training program about parafunctional activities of patients having bruxism with myofascial temporomandibular disorders. The program includes stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises.
Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.
Arm Title
Telerehabilitation Group
Arm Type
Experimental
Arm Description
The program includes the same stretching and strengthening of masticatory and neck muscles and posture exercises as well as diaphragmatic breathing exercises using telerehabilitation once a week by video call, and reminder messages will be sent to the patients 3 times a week.
Relaxation: Relaxation exercises with diaphragmatic breathing Posture Exercise: Rest position of tongue and TMJ, head and neck posture correction exercises Stretching Exercises: Stretching exercises for chewing muscles, cervical muscles, and pectoral muscles Strengthening: The neck will consist of strengthening exercises for deep flexor muscles, suprahyoid and infrahyoid muscles, and scapular retractors.
Intervention Type
Procedure
Intervention Name(s)
Home Exercise Group
Intervention Description
Educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
Intervention Type
Procedure
Intervention Name(s)
Telerehabilitation Group
Intervention Description
Telerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
Primary Outcome Measure Information:
Title
Change from Baseline in Pain at 4 weeks and 8 weeks
Description
Visual Analog Scale will be used where patients will be asked to rate their pain on a scale from 0 to 10 with 0 indicating no pain and 10 the maximum worst pain, at the baseline and the end of 4 weeks intervention and at the end 8 weeks from baseline.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Mandibular range of movements at 4 weeks and 8 weeks
Description
Maximum mouth opening, mandibular lateral right and left shift, and mandibular protrusion range of motion measurements in mm.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Neck disability at 4 weeks and 8 weeks
Description
Neck Disability Index, consisting of a total of ten titles, was developed by Vernon and Mior in 1991. It includes topics such as pain intensity in the neck, personal care, lifting, reading, headaches, concentration, driving, sleep, and leisure activities. The maximum score is 50, while the minimum is 0 points.
Classification according to total score is as follows: 0-4 (no restrictions); 5-14 (mild restriction); 15-24 (moderate restriction); 25-34 (severe limitation); 34 and above (completely limited).
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Headache at 4 weeks and 8 weeks
Description
Headache Impact Test-6 test consists of 6 questions about the severity of headache, the effect of pain on daily life activities, how often it causes fatigue and low motivation, and concentration impairment. Scoring is done between 36-78.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Sleep Quality at 4 weeks and 8 weeks
Description
Pittsburg Sleep Quality Index test is used to evaluate sleep effects in the last few months. This questionnaire contains 24 questions, 19 of which are personal, and 5 of which are to be answered by a partner about sleep during both day and night. Five questions answered by the partner are not included in the scoring. Self-assessment questions contain different items related to sleep quality, which provide information about sleep duration, latency, and the frequency and severity of specific sleep problems. The total score is between 0-21. A score of 5 and below indicates good sleep quality, and a score above 5 indicates poor sleep quality.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Oral Behavior at 4 weeks and 8 weeks
Description
Evaluation of oral habits with the Oral Habits Questionnaire consisting of 21 items, each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; 1 = several times or 0 = none". The questions cover the times of sleep and wakefulness. The overall score ranges from 0 to 84.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Quality of life at 4 weeks and 8 weeks
Description
The individual's personal perception of how oral health affects their quality of life and general health is measured. Oral Health Impact Profile-14 is a scale system that evaluates this perception with questions for functional limitation, physical pain, psychological discomfort, physical, psychological and social inadequacy, and disability measures. It is concluded that as the total score increases, the severity of the problem increases, and the quality of life decreases.
Time Frame
Baseline, 4 weeks, 8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks
Description
Forward Head Posture: The angle between the C7-Ear-Horizontal plane in the sitting position (in degrees with a goniometer) Shoulder Posture: The angle between the Acromion-C7-Horizontal Plane in the sitting position (in degrees with a goniometer).
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Anxiety at 4 weeks and 8 weeks
Description
The State-Trait Anxiety Inventory was developed by Spielberger et al. to measure state anxiety and trait anxiety. The questionnaire consists of 40 questions, the expressions used by the person in expressing his own feelings were included. There are four categories (nothing-a little-much-completely) for answers.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change from Baseline in Fatigue at 4 weeks and 8 weeks
Description
The Fatigue Severity Scale is used to measure the severity of fatigue in the past week, including today. The questionnaire consists of 9 items in total, and participants are asked to give a score from 1 to 7 for each question. The fatigue level of the patient is determined according to the score obtained by the sum of the points. The higher the level of fatigue, the higher the total score.
Time Frame
Baseline, 4 weeks, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages between 18 and 65 years old
Patients with TMD in the myofascial Group Ia, Ib according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) and diagnosed with bruxism
Having pain ≥ 3 according to the Visual Analog Scale
Those who have not received medical treatment for the last 3 months and will not receive it during the treatment process will be included in the study.
Exclusion Criteria:
Ages under 18 and over 65 years old
Patients with disc displacement and/or TMJ degeneration
Patients who have orthodontic or splint treatment
Patients with musculoskeletal problems in which systemic specific pathological conditions such as cervical and/or temporomandibular joint (TMJ) problem malignancy, fracture, the rheumatoid disease is proven
Patients who have undergone any surgery related to the cervical and/or TMJ
Patients with facial paralysis
Patients who regularly use analgesic or anti-inflammatory drugs
Patients who have received physical therapy associated with TMJ in less than 3 months
Patients with a history of trauma (whiplash injury, condylar trauma, fracture)
Patients with cognitive deficits
Participation rate lower than 80% of the program schedule
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aysenur Tuncer
Phone
+90 342 2118080
Ext
2110
Email
aysenur.tuncer@hku.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysenur Tuncer
Organizational Affiliation
Hasan Kalyoncu University
Official's Role
Study Director
Facility Information:
Facility Name
Hasan Kalyoncu University
City
Gaziantep
ZIP/Postal Code
27010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezgi H Giray
Phone
+90 342 2118080
Email
ezgiray1@gmail.com
First Name & Middle Initial & Last Name & Degree
Ezgi H Giray
12. IPD Sharing Statement
Learn more about this trial
Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism
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