Tension-Type HeadacheNCT05058573
Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache
A study of Tension-Type Headache, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this course is to investigate the effect of temporomandibular joint relaxation and myofacial relaxation techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2021to 15 Nov 2021
- 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
- individuals diagnosed with tension-type headache by a specialist physician
- individuals diagnosed with Temporomandibular joint dysfunction by dentist-maxillofacial surgeon
- To be able to read and understand Turkish
- Have not received any medical treatment in the last 1 year.
Who cannot join
- who received physical therapy for TMED in the previous 6 months
- who with any neurological problems
- who with any mental prolems
- who with any konjenital disorders
- who have undergone any cervikal or cranial surgery
- who have any facial trauma or facial paralyses
Show all 9Show fewer
- who have advanced cervikal disc herniation
- who have ankylosing spondlitis, rhematoid arthritis, fibromyalgia
- who have any cominication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Quality of Life, Depression and Headache in Individuals With Tension Headache
The aim of this course is to investigate the effect of temporomandibular joint relaxation and myofacial relaxation techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache.
Read the detailed description
One of the most common complaints in society is headaches. Headaches affect the quality of life of people and communities.The proportion of people who have experienced headaches at least once in their lifetime is more than 90% in society, 93% in men and 99% in women.The causes that are common and cause this discomfort are basically examined under two main groups.These are grouped as 'primary/primary type headaches and secondary/secondary type headaches'. Some studies in literature have reported that temporomandibular dysfunction and headaches are 'comorbid diseases', that the presence of one will increase the symptoms of the other, and that if the temporomandibular joint disorder and headchache occur together, symptoms will shows sooner than expected.Some studies in literature have reported that temporomandibular dysfunction and headaches are 'comorbid diseases', that the presence of one will increase the symptoms of the other, and that if the temporomandibular joint disorder and the tension headaches occur together, it will show symptoms sooner than expected. The International Classification of Headache Disorders decodes the relationship between temporomandibular joint dysfunctions and headache.it is mentioned that as headache attributed to temporomandibular joint disorders. Many common points in studies have shown the Association of temporomandibular dysfunction and tension-type headache. The temporomandibular joint, one of the most complex joints in the body, is a loose joint that harmonizes between the mandibular condyle and the mandibular Fossa of the temporal bone decoction. The skull is the only movable joint between the bones decoction.November: the head and neck are a part of the stomatognathic system (masticatory system), which includes the muscles of the neck, chewing November, teeth-ligaments and salivary glands.Temporomandibular joint disorders are a major problem, covering approximately 5% to 12% of the population.Temporomandibular joint dysfunction leads to headaches, stiffness-pain in the jaw, restriction in jaw movements and stress increases TMD has been noted that the patients have difficulty doing daily life activities. Most Temporomandibular joint problems occur when the muscles around the joint are affected and pain occurs during the movements of the mandible and decreased functional use of the temporomandibular November. The muscles in the cervical region are also responsible for ensuring the stable position of the head, as well as for stabilizing the neck during movements of the jaw November. All November, the muscles in the craniocervical and facial region are connected. Temporomandibular joint dysfunctions (TMED) are more common in people with episodic tension headache (EGBTA) , migraine, and chronic tension headache (KGTBA) than in those without headache. When we look at literature, there are a limited number of studies in patients with Temporomandibular joint dysfunction with tension-type headache. Our study aimed to examine the effectiveness of temporomandibular joint relaxation and myofacial techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache.
- Conditions
- Tension-Type Headache
- Being tested
- Control group (n=22)
- Keywords
- Tension - Type Headache, Temporomandibular Joint Disorder, Myofascial Release Techniques, Temporomandibular joint release techniques, Physiotherapy
- Medical subject headings
- Tension-Type Headache, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (n=22)Other
Control group will be received only medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22) | Experimental | medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles), Receives: Other: Control group (n=22) |
| Temporomandibular joint release techniques group (n=22) | Experimental | only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles). Receives: Other: Control group (n=22) |
| Control group (n=22) | Experimental | only medication treatment will be applied Receives: Other: Control group (n=22) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervikal region range of motion measurement
Cases will be shown and asked to perform head flexion, extension, lateral flexion and rotation movements. And active joint range of motion will be evaluated with goniometer.
Measured: "baseline,preintervention " and "immediately after the intervention"
Temporomandibular joint range of motion measurement
In our study, the maximum mouth opening amount of individuals in the group will be measured with a millimeter ruler 'right , left and side movements of the jaw (laterotrusion), forward movement (protrusion) and back movement (retrusion)'.
Measured: "baseline,preintervention " and "immediately after the intervention"
Fonseca Questionnare
In order to classify Temporomandibular joint dysfunction, the Fonseca questionnaire will be applied. this questionnaire consists of 10 questions. Participants are asked to answer each question in the form of Yes (10 points), Sometimes (5 points ), No (0 points). Scores of all questions are collected and the severity of temporomandibular joint dysfunction is determined. TMED-No (0-15 points), Mild-TMED (20-40 points), Moderate-TMED (45-60 points) and Severe - TMED (70-100 points).
Measured: "baseline,preintervention " and "immediately after the intervention"
Headache Impact Test
This questionnaire describes the frequency of a person's headache, the degree of restriction in daily life activities and social settings due to headaches , their psychological state , changes in their cognitive function.
Measured: "baseline,preintervention " and "immediately after the intervention"
Beck depression scale
In order to evaluate depression level, The beck depression scale will be used.in the scale consisting of 21 questions, each question consists of 4 styles. The questions are scored between 0-3 points dec Low scores represent good results. According to the scores obtained, (0-9) points indicate minimal depression, (10-16) points indicate mild depression, (17-29) points indicate moderate depression, and (30-63) points indicate severe depression
Measured: "baseline,preintervention " and "immediately after the intervention"
Beck Anxiety Sacle
In order to evaluate anxiety level, The beck depression scale will be used.in this scale consisting of 21 items, a quadruple Likert type measurement is performed. 0 points = none ,1 point = light , 2 points =medium , 3 points = serious. the december of 8-15 points is expressed as mild anxiety symptoms, moderate anxiety dec 16-25 points, severe anxiety symptoms from 26-63 points.
Measured: "baseline,preintervention " and "immediately after the intervention"
General short form quality of life scale
In order to evaluate the quality of life, the short form quality of life will be used.SF-36 is a test consisting of 36 items used to obtain information about a person's physical, emotional, and general health status. This test includes 8 subscales ; mental state ,energy, pain, physical function, limitation due to physical problems, restriction due to emotional problems, social function and general health. it is evaluated with a score of 0-100 points.dec. High marks indicate a good state of health.
Measured: "baseline,preintervention " and "immediately after the intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start10 Apr 2021
- Primary completion10 Jun 2021
- Study completion15 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
- Investigators
- Hanifegül Taşkıran, Prof. Dr, Study chair, İstanbul Aydın UniversityMustafa Zafer DEMİRTAŞ, MD, Study director, Alanya Alaaddin Keykubat UniversityErtan KARAÇAY, MD, Study director, Alanya Alaaddin Keykubat UniversityAhmet ÖZŞİMŞEK, PHD MD, Study director, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058573
- Sponsor's protocol ID
- 10354421-2021/07-08
- Status last verified
- Nov 2021
- First submitted
- 9 Sep 2021
- Last updated
- 9 Nov 2021
- 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 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Quality of Life, Depression and Headache in Individuals With Tension Headache
- ClinicalTrials.gov ID
- NCT05058573
- Acronym / sponsor ID
- 10354421-2021/07-08
- Conditions
- Tension-Type Headache
- Keywords
- Tension - Type Headache, Temporomandibular Joint Disorder, Myofascial Release Techniques, Temporomandibular joint release techniques, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 15 Nov 2021 (estimated)
- First posted
- 27 Sep 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 this course is to investigate the effect of temporomandibular joint relaxation and myofacial relaxation techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache.
Detailed description
One of the most common complaints in society is headaches. Headaches affect the quality of life of people and communities.The proportion of people who have experienced headaches at least once in their lifetime is more than 90% in society, 93% in men and 99% in women.The causes that are common and cause this discomfort are basically examined under two main groups.These are grouped as 'primary/primary type headaches and secondary/secondary type headaches'. Some studies in literature have reported that temporomandibular dysfunction and headaches are 'comorbid diseases', that the presence of one will increase the symptoms of the other, and that if the temporomandibular joint disorder and headchache occur together, symptoms will shows sooner than expected.Some studies in literature have reported that temporomandibular dysfunction and headaches are 'comorbid diseases', that the presence of one will increase the symptoms of the other, and that if the temporomandibular joint disorder and the tension headaches occur together, it will show symptoms sooner than expected. The International Classification of Headache Disorders decodes the relationship between temporomandibular joint dysfunctions and headache.it is mentioned that as headache attributed to temporomandibular joint disorders. Many common points in studies have shown the Association of temporomandibular dysfunction and tension-type headache. The temporomandibular joint, one of the most complex joints in the body, is a loose joint that harmonizes between the mandibular condyle and the mandibular Fossa of the temporal bone decoction. The skull is the only movable joint between the bones decoction.November: the head and neck are a part of the stomatognathic system (masticatory system), which includes the muscles of the neck, chewing November, teeth-ligaments and salivary glands.Temporomandibular joint disorders are a major problem, covering approximately 5% to 12% of the population.Temporomandibular joint dysfunction leads to headaches, stiffness-pain in the jaw, restriction in jaw movements and stress increases TMD has been noted that the patients have difficulty doing daily life activities. Most Temporomandibular joint problems occur when the muscles around the joint are affected and pain occurs during the movements of the mandible and decreased functional use of the temporomandibular November. The muscles in the cervical region are also responsible for ensuring the stable position of the head, as well as for stabilizing the neck during movements of the jaw November. All November, the muscles in the craniocervical and facial region are connected. Temporomandibular joint dysfunctions (TMED) are more common in people with episodic tension headache (EGBTA) , migraine, and chronic tension headache (KGTBA) than in those without headache. When we look at literature, there are a limited number of studies in patients with Temporomandibular joint dysfunction with tension-type headache. Our study aimed to examine the effectiveness of temporomandibular joint relaxation and myofacial techniques on quality of life , Joint range of motion, headache, depression in individuals with tension type headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22) | Experimental | Other: Control group (n=22)medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles), |
| Temporomandibular joint release techniques group (n=22) | Experimental | Other: Control group (n=22)only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles). |
| Control group (n=22) | Experimental | Other: Control group (n=22)only medication treatment will be applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals diagnosed with tension-type headache by a specialist physician
- individuals diagnosed with Temporomandibular joint dysfunction by dentist-maxillofacial surgeon
- To be able to read and understand Turkish
- Have not received any medical treatment in the last 1 year.
Key exclusion criteria (9 listed)
- who received physical therapy for TMED in the previous 6 months
- who with any neurological problems
- who with any mental prolems
- who with any konjenital disorders
- who have undergone any cervikal or cranial surgery
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 |
|---|---|---|
| Control group (n=22)Control group will be received only medical treatment | Other | Control group (n=22), Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22), Temporomandibular joint release techniques group (n=22) |
Primary outcome
Cervikal region range of motion measurement
Time frame: "baseline,preintervention " and "immediately after the intervention"
Cases will be shown and asked to perform head flexion, extension, lateral flexion and rotation movements. And active joint range of motion will be evaluated with goniometer.
Temporomandibular joint range of motion measurement
Time frame: "baseline,preintervention " and "immediately after the intervention"
In our study, the maximum mouth opening amount of individuals in the group will be measured with a millimeter ruler 'right , left and side movements of the jaw (laterotrusion), forward movement (protrusion) and back movement (retrusion)'.
Fonseca Questionnare
Time frame: "baseline,preintervention " and "immediately after the intervention"
In order to classify Temporomandibular joint dysfunction, the Fonseca questionnaire will be applied. this questionnaire consists of 10 questions. Participants are asked to answer each question in the form of Yes (10 points), Sometimes (5 points ), No (0 points). Scores of all questions are collected and the severity of temporomandibular joint dysfunction is determined. TMED-No (0-15 points), Mild-TMED (20-40 points), Moderate-TMED (45-60 points) and Severe - TMED (70-100 points).
Headache Impact Test
Time frame: "baseline,preintervention " and "immediately after the intervention"
This questionnaire describes the frequency of a person's headache, the degree of restriction in daily life activities and social settings due to headaches , their psychological state , changes in their cognitive function.
Beck depression scale
Time frame: "baseline,preintervention " and "immediately after the intervention"
In order to evaluate depression level, The beck depression scale will be used.in the scale consisting of 21 questions, each question consists of 4 styles. The questions are scored between 0-3 points dec Low scores represent good results. According to the scores obtained, (0-9) points indicate minimal depression, (10-16) points indicate mild depression, (17-29) points indicate moderate depression, and (30-63) points indicate severe depression
Beck Anxiety Sacle
Time frame: "baseline,preintervention " and "immediately after the intervention"
In order to evaluate anxiety level, The beck depression scale will be used.in this scale consisting of 21 items, a quadruple Likert type measurement is performed. 0 points = none ,1 point = light , 2 points =medium , 3 points = serious. the december of 8-15 points is expressed as mild anxiety symptoms, moderate anxiety dec 16-25 points, severe anxiety symptoms from 26-63 points.
General short form quality of life scale
Time frame: "baseline,preintervention " and "immediately after the intervention"
In order to evaluate the quality of life, the short form quality of life will be used.SF-36 is a test consisting of 36 items used to obtain information about a person's physical, emotional, and general health status. This test includes 8 subscales ; mental state ,energy, pain, physical function, limitation due to physical problems, restriction due to emotional problems, social function and general health. it is evaluated with a score of 0-100 points.dec. High marks indicate a good state of health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
Related trials for Tension-Type Headache
Recruiting
Efficacy and Safety of Ultrasound-Guided Pharmacopuncture as an Adjunctive Therapy in Inpatients With Post-Traffic Accident Tension-Type Headache
Pharmacologic Action
RecruitingPhase 4
Treatment of Tension-type Headache by Zhixuan Analgesic Tablets
Frequent Episodic Tension-Type Headache
Not yet recruitingObservational study
Prevalence of Primary Headache in Multiple Sclerosis Patients
Multiple Sclerosis, Primary Headache Disorders
Not yet recruitingObservational study
Tension-type Headache and Its Association
Tension-Type Headache, Sleep Disturbance
Recruiting
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
Acute Headache, Migraine
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.
Hanifegül Taşkıran, Prof. Dr study chair
İstanbul Aydın University
Mustafa Zafer DEMİRTAŞ, MD study director
Alanya Alaaddin Keykubat University
Ertan KARAÇAY, MD study director
Alanya Alaaddin Keykubat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Tension-Type Headache, run by Alanya Alaaddin Keykubat 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 9 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. 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?
Results are not available in the source record.
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?
Cervikal region range of motion measurement (time frame: "baseline,preintervention " and "immediately after the intervention"). 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 9 Nov 2021.