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Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache

Primary Purpose

Tension-Type Headache

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control group (n=22)
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring Tension - Type Headache, Temporomandibular Joint Disorder, Myofascial Release Techniques, Temporomandibular joint release techniques, Physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • who have advanced cervikal disc herniation
  • who have ankylosing spondlitis, rhematoid arthritis, fibromyalgia
  • who have any cominication problems

Sites / Locations

  • Alanyaaku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22)

Temporomandibular joint release techniques group (n=22)

Control group (n=22)

Arm Description

medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles),

only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles).

only medication treatment will be applied

Outcomes

Primary Outcome Measures

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.
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)'.
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).
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.
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2021
Last Updated
November 6, 2021
Sponsor
Alanya Alaaddin Keykubat University
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1. Study Identification

Unique Protocol Identification Number
NCT05058573
Brief Title
Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache
Official Title
Effect of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Quality of Life, Depression and Headache in Individuals With Tension Headache
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
November 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache
Keywords
Tension - Type Headache, Temporomandibular Joint Disorder, Myofascial Release Techniques, Temporomandibular joint release techniques, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled study
Masking
Participant
Masking Description
it was calculated that 80% power could be achieved at a 95% confidence level when at least 66 people (at least 22 people for each group) were taken into the study. Therefore, our study Decocking TMJ+myofascial release+ a classic medical treatment (N= 25), TMJ Decocking+ classical medical treatment (N= 25), just the usual medical therapy (N=25) Group 3 group to be 75 individuals will be included. Assessments will be made before and after treatment. Treatment will be carried out in the form of 8 sessions in an average of 20-30 minute sessions 2 days a week for 4 weeks.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22)
Arm Type
Experimental
Arm Description
medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles),
Arm Title
Temporomandibular joint release techniques group (n=22)
Arm Type
Experimental
Arm Description
only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles).
Arm Title
Control group (n=22)
Arm Type
Experimental
Arm Description
only medication treatment will be applied
Intervention Type
Other
Intervention Name(s)
Control group (n=22)
Intervention Description
Control group will be received only medical treatment
Primary Outcome Measure Information:
Title
Cervikal region range of motion measurement
Description
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.
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Temporomandibular joint range of motion measurement
Description
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)'.
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Fonseca Questionnare
Description
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).
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Headache Impact Test
Description
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.
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Beck depression scale
Description
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
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
Beck Anxiety Sacle
Description
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.
Time Frame
"baseline,preintervention " and "immediately after the intervention"
Title
General short form quality of life scale
Description
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.
Time Frame
"baseline,preintervention " and "immediately after the intervention"

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: 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. Exclusion Criteria: 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 who have advanced cervikal disc herniation who have ankylosing spondlitis, rhematoid arthritis, fibromyalgia who have any cominication problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanifegül Taşkıran, Prof. Dr
Organizational Affiliation
İstanbul Aydın University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mustafa Zafer DEMİRTAŞ, MD
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ertan KARAÇAY, MD
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmet ÖZŞİMŞEK, PHD MD
Organizational Affiliation
Alanya Alaaddin Keykubat University
Official's Role
Study Director
Facility Information:
Facility Name
Alanyaaku
City
Antalya
State/Province
Alanya
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache

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