Myofascial PainNCT04884152
Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism
A study testing Home Exercise Group and Telerehabilitation Group in people with Myofascial Pain and Temporomandibular Disorder, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Myofascial Pain, Temporomandibular Disorder, Bruxism
- What is being tested?
- Home Exercise Group and Telerehabilitation Group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2021to 30 Aug 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
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism
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.
Read the 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.
- Conditions
- Myofascial Pain, Temporomandibular Disorder, Bruxism
- Being tested
- Home Exercise Group, Telerehabilitation Group
- Keywords
- Myofascial Pain, Temporomandibular Disorder, Bruxism, Telerehabilitation
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Exercise GroupProcedure or surgery
Educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
Telerehabilitation GroupProcedure or surgery
Telerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Group | Active comparator | 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. Receives: Procedure: Home Exercise Group |
| Telerehabilitation Group | Experimental | 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. Receives: Procedure: Telerehabilitation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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).
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (3)
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).
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start3 May 2021
- Primary completion30 Jun 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Hatice Giray, Hasan Kalyoncu University
- Investigators
- Aysenur Tuncer, Study director, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884152
- Sponsor's protocol ID
- 2021/012
- Status last verified
- Aug 2022
- First submitted
- 6 May 2021
- Last updated
- 10 Jan 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Telerehabilitation in Individuals Myofascial Temporomandibular Dysfunction With Bruxism
- ClinicalTrials.gov ID
- NCT04884152
- Acronym / sponsor ID
- 2021/012
- Conditions
- Myofascial Pain, Temporomandibular Disorder, Bruxism
- Keywords
- Myofascial Pain, Temporomandibular Disorder, Bruxism, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Group | Active comparator | Procedure: Home Exercise GroupThe 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. |
| Telerehabilitation Group | Experimental | Procedure: Telerehabilitation GroupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Home Exercise GroupEducational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders. | Procedure or surgery | Home Exercise Group |
| Telerehabilitation GroupTelerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders. | Procedure or surgery | Telerehabilitation Group |
Primary outcome
Change from Baseline in Pain at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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
Time frame: Baseline, 4 weeks, 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.
3 secondary outcomes
Change from Baseline in Head and Shoulder Posture at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Change from Baseline in Anxiety at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 weeks
Change from Baseline in Fatigue at 4 weeks and 8 weeks
Time frame: Baseline, 4 weeks, 8 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 10 Jan 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. This study is not recruiting at the moment.
Aysenur Tuncer study director
Hasan Kalyoncu 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 Home Exercise Group and Telerehabilitation Group in people with Myofascial Pain and Temporomandibular Disorder, run by Hasan Kalyoncu 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 11 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 10 Jan 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?
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?
Change from Baseline in Pain at 4 weeks and 8 weeks (time frame: Baseline, 4 weeks, 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 10 Jan 2024.