Temporomandibular DisorderNCT04294602
Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
A study testing Exercise, Low Level Laser Therapy and Manuel Pressure Release in people with Temporomandibular Disorder, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Exercise, Low Level Laser Therapy and Manuel Pressure Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2017to 10 May 2018
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Cases who have 3 or more symptoms related to TMJ problems
- cases who have trigger points in cervical and masticatory muscles
- cases who TMD detected by the dentist,
- being between the ages of 18-30,
- volunteer to participate in the study
Who cannot join
- Patients with a positive history of trauma in the face and neck area and neurological disorders
- patients undergoing TMJ or cervical region surgery in the last 3 months,
- patients who used dental orthotics within 1 month,
- patients who have TMJ instability,
- patients who have cervical and upper thoracic region,
- patients who have active infection and chronic pain, such as trigeminal neuralgia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.
Read the detailed description
59 persons with TMD diagnosed by the dentist and with cervical myofascial pain, aged 18-30 years will be randomly allocated, 3 groups. The participants were randomly allocated only exercise group (EG) (n=20), low-level laser therapy plus exercise group (LLLT) (n=17) and manual pressure release plus exercise group (MPR) (n=22). The cases were evaluated and treated by the same physiotherapist for 4 weeks (12 sessions).
Pain, pain pressure threshold, temporomandibular joint (TMJ) mobility and disability, forward head posture, head rotation, neck disability, psychological status and quality of life were evaluated. Evaluations were repeated before and after treatment.
- Conditions
- Temporomandibular Disorder
- Being tested
- Exercise, Low Level Laser Therapy, Manuel Pressure Release, Patient Education
- Keywords
- Temporomandibular disorders, Exercise, Low-level laser therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern.
Low Level Laser TherapyOther
LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points.
Manuel Pressure ReleaseOther
MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, manuel pressure applied trigger point in neck and mactication muscles
Patient EducationOther
Some suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | This group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks. Receives: Other: Exercise; Other: Patient Education |
| Low Level Laser Therapy Program | Experimental | This group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks. Receives: Other: Exercise; Other: Low Level Laser Therapy; Other: Patient Education |
| Manual Pressure Release Program | Experimental | ThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks. Receives: Other: Exercise; Other: Manuel Pressure Release; Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold Assessment
Pressure Pain Threshold (PPT) of an individual's mastication and cervical muscle was measured with an algometer (JTECH Medical Industries, CommanderTMAlgometer), and the applied pressure was increased to 1 cm2/ kg per second. PPT measurements were repeated three times and the average was used for analysis in every participant.
Measured: Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.
Pain Severity Assessment
To evaluate the general pain severity of the patients, the Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters
Measured: Change from baseline TMJ pain and intensity of head pain, TMJ noise and jaw locking score at week 4.
Jaw Movements Assessment
Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.
Measured: Change from baseline MMO and lateral deviation score at week 4.
Neck Movements Assessment
Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.
Measured: Change from baseline cervical rotations and craniovertebral angle score at week 4.
Temporomandibular Disorder Severity
The TMD severity in participation is defined by the Craniomandibular Index (CMI) which was developed to provide a standardized measure to the severity of problems in mandibular movement, muscle, and joint tenderness and TMJ noise for use in epidemiological and clinical outcome studies. The instrument was designed to have clearly defined objective criteria, simple clinical methods, and ease in scoring; it is divided into the Palpation Index (PI) and the Dysfunction Index (DI). The means of the subscales were averaged to produce a CMI score ranging from 0 (best) to 1 (worst)
Measured: Change from baseline temporomandibular disorder severity score at week 4
Quality of Life Assesment
Short Form-36 questionnaire contains the physical and mental component, which is evaluated, is close to 100, indicating an increase in health-related quality of life. The means SF-36 score ranging from 0 (worst) to 100 (best).
Measured: Change from baseline quality of life score at week 4
Secondary outcomes (2)
Neck Disability Assesment
Northwick Park Neck Pain Questionnaire; Neck pain severity, neck pain and sleep, numbness and tingling in the arms at night, duration of symptoms and complaints, weight-bearing, reading and watching television, work and housework, social activities and driving includes 9 items. Each item consists of 5 options, the level of disability increases as you approach 36 points. The means northwick park neck pain questionnaire score ranging from 0 (best) to 36 (worst).
Measured: Change from baseline neck disability score at week 4.
Psychological Status Assesment
Beck depression index which is a two-factor scale, emotion and somatic, has 21 questions, the lowest score is 0 and the highest score is 3 in each question. The means Beck depression index score ranging from 0 (best) to 63 (worst).
Measured: Change from baseline psychological status score at week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start15 May 2017
- Primary completion13 Mar 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Randomized Controlled Study
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Principal investigator, Abdurrahman Tanhan, Bitlis Eren University
- Investigators
- Abdurrahman TANHAN, MSc, Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294602
- Sponsor's protocol ID
- BitlisErenU1
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT04294602
- Acronym / sponsor ID
- BitlisErenU1
- Conditions
- Temporomandibular Disorder
- Keywords
- Temporomandibular disorders, Exercise, Low-level laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 15 May 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 4 Mar 2020 (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 this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful TMD.
Detailed description
59 persons with TMD diagnosed by the dentist and with cervical myofascial pain, aged 18-30 years will be randomly allocated, 3 groups. The participants were randomly allocated only exercise group (EG) (n=20), low-level laser therapy plus exercise group (LLLT) (n=17) and manual pressure release plus exercise group (MPR) (n=22). The cases were evaluated and treated by the same physiotherapist for 4 weeks (12 sessions).
Pain, pain pressure threshold, temporomandibular joint (TMJ) mobility and disability, forward head posture, head rotation, neck disability, psychological status and quality of life were evaluated. Evaluations were repeated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Other: Exercise, Other: Patient EducationThis group received therapeutic exercises and patient education. For patients to encounter fewer problems and to reduce their problems, some recommendations were made that should be taken into consideration in daily life. These suggestions were given in writing. The exercise program included muscle stretching, massage of painful muscles, guided opening and closing movements, gentle isometric tension exercises against resistance, correction of body posture and relaxation techniques. All exercises were done in 6 repetitions a set, 3 sets a day, 3 days a week, treatment program lasted 4 weeks. |
| Low Level Laser Therapy Program | Experimental | Other: Exercise, Other: Low Level Laser Therapy, Other: Patient EducationThis group received LLLT, therapeutic exercises and patient education in the therapy programs. LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. The application was applied to MTrP or sensitive points in the mastication and cervical muscles.LLLT program was done in 3 days a week, the treatment program lasted 4 weeks. |
| Manual Pressure Release Program | Experimental | Other: Exercise, Other: Manuel Pressure Release, Other: Patient EducationThisThis group received manual pressure release (MPR), therapeutic exercises and patient education in the therapy programs. MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, MTrPs in the mastication and neck muscle. Applied pressure gradually with finger over the MTrPs until the subject reported a 'moderate but easily tolerable' pain value of 7 out of 10. When the pain value decreased to at least 3 or 4 therapist increased pressure again until discomfort and/or pain appeared again. This process was repeated until there was no MTrP tension/tenderness or 60 s had elapsed. MPR program was done in 3 days a week, the treatment program lasted 4 weeks. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Cases who have 3 or more symptoms related to TMJ problems
- cases who have trigger points in cervical and masticatory muscles
- cases who TMD detected by the dentist,
- being between the ages of 18-30,
- volunteer to participate in the study
Key exclusion criteria (6 listed)
- Patients with a positive history of trauma in the face and neck area and neurological disorders
- patients undergoing TMJ or cervical region surgery in the last 3 months,
- patients who used dental orthotics within 1 month,
- patients who have TMJ instability,
- patients who have cervical and upper thoracic region,
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 |
|---|---|---|
| ExerciseExercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern. | Other | Exercise Program, Low Level Laser Therapy Program, Manual Pressure Release Program |
| Low Level Laser TherapyLLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points. | Other | Low Level Laser Therapy Program |
| Manuel Pressure ReleaseMPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, manuel pressure applied trigger point in neck and mactication muscles | Other | Manual Pressure Release Program |
| Patient EducationSome suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing. | Other | Exercise Program, Low Level Laser Therapy Program, Manual Pressure Release Program |
Primary outcome
Pressure Pain Threshold Assessment
Time frame: Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.
Pressure Pain Threshold (PPT) of an individual's mastication and cervical muscle was measured with an algometer (JTECH Medical Industries, CommanderTMAlgometer), and the applied pressure was increased to 1 cm2/ kg per second. PPT measurements were repeated three times and the average was used for analysis in every participant.
Pain Severity Assessment
Time frame: Change from baseline TMJ pain and intensity of head pain, TMJ noise and jaw locking score at week 4.
To evaluate the general pain severity of the patients, the Visual Analog Scale (VAS), which is the Visual Pain Scale of Turkish, was used. Patients were asked to mark their general pain separately on a 10 cm scale. According to this, "0" indicates that there is no pain, and "10" indicates the most severe pain. The distance between the marked point and the beginning of the line was recorded in centimeters
Jaw Movements Assessment
Time frame: Change from baseline MMO and lateral deviation score at week 4.
Maximum mouth opening (MMO) and lateral deviation were measured with a caliper.
Neck Movements Assessment
Time frame: Change from baseline cervical rotations and craniovertebral angle score at week 4.
Cervical rotations and the craniovertebral angle between C7 and tragus were measured by a goniometer.
Temporomandibular Disorder Severity
Time frame: Change from baseline temporomandibular disorder severity score at week 4
The TMD severity in participation is defined by the Craniomandibular Index (CMI) which was developed to provide a standardized measure to the severity of problems in mandibular movement, muscle, and joint tenderness and TMJ noise for use in epidemiological and clinical outcome studies. The instrument was designed to have clearly defined objective criteria, simple clinical methods, and ease in scoring; it is divided into the Palpation Index (PI) and the Dysfunction Index (DI). The means of the subscales were averaged to produce a CMI score ranging from 0 (best) to 1 (worst)
Quality of Life Assesment
Time frame: Change from baseline quality of life score at week 4
Short Form-36 questionnaire contains the physical and mental component, which is evaluated, is close to 100, indicating an increase in health-related quality of life. The means SF-36 score ranging from 0 (worst) to 100 (best).
2 secondary outcomes
Neck Disability Assesment
Time frame: Change from baseline neck disability score at week 4.
Psychological Status Assesment
Time frame: Change from baseline psychological status score at week 4.
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 4 Mar 2020.
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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.
Abdurrahman TANHAN, MSc principal investigator
Bitlis Eren 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 Exercise, Low Level Laser Therapy and Manuel Pressure Release in people with Temporomandibular Disorder, run by Bitlis Eren 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 5 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: finished, as of the sponsor's last update on 4 Mar 2020. 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?
Pressure Pain Threshold Assessment (time frame: Change from baseline pressure pain threshold score in neck and mastication muscles at week 4.). The study lists 6 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 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.