- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05058573
Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache
6. November 2021 aktualisiert von: Ayça Araci, Alanya Alaaddin Keykubat University
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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
66
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Alanya
-
Antalya, Alanya, Truthahn
- Alanyaaku
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Myofascial relaxation technique + Temporomandibular joint release techniques group (n=22)
medical treatment + temporomandibular joint relaxation (temporalis, masseter, and suboccipital muscles) + myofasial release/trigger points (trapezius, rhomboideus, and levator scapulae, sternocleidomastoideus muscles),
|
Control group will be received only medical treatment
|
Experimental: Temporomandibular joint release techniques group (n=22)
only temporomandibular joint relaxation will be performed in this group (temporalis, masseter, and suboccipital muscles).
|
Control group will be received only medical treatment
|
Experimental: Control group (n=22)
only medication treatment will be applied
|
Control group will be received only medical treatment
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Cervikal region range of motion measurement
Zeitfenster: "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.
|
"baseline,preintervention " and "immediately after the intervention"
|
Temporomandibular joint range of motion measurement
Zeitfenster: "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)'.
|
"baseline,preintervention " and "immediately after the intervention"
|
Fonseca Questionnare
Zeitfenster: "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).
|
"baseline,preintervention " and "immediately after the intervention"
|
Headache Impact Test
Zeitfenster: "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.
|
"baseline,preintervention " and "immediately after the intervention"
|
Beck depression scale
Zeitfenster: "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
|
"baseline,preintervention " and "immediately after the intervention"
|
Beck Anxiety Sacle
Zeitfenster: "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.
|
"baseline,preintervention " and "immediately after the intervention"
|
General short form quality of life scale
Zeitfenster: "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.
|
"baseline,preintervention " and "immediately after the intervention"
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienstuhl: Hanifegül Taşkıran, Prof. Dr, İstanbul Aydın University
- Studienleiter: Mustafa Zafer DEMİRTAŞ, MD, Alanya Alaaddin Keykubat University
- Studienleiter: Ertan KARAÇAY, MD, Alanya Alaaddin Keykubat University
- Studienleiter: Ahmet ÖZŞİMŞEK, PHD MD, Alanya Alaaddin Keykubat University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
10. April 2021
Primärer Abschluss (Tatsächlich)
10. Juni 2021
Studienabschluss (Voraussichtlich)
15. November 2021
Studienanmeldedaten
Zuerst eingereicht
9. September 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
17. September 2021
Zuerst gepostet (Tatsächlich)
27. September 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. November 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. November 2021
Zuletzt verifiziert
1. November 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Bewegungsapparates
- Muskelerkrankungen
- Stomatognathe Erkrankungen
- Kopfschmerzerkrankungen, primär
- Kopfschmerzen
- Kiefererkrankungen
- Kraniomandibuläre Erkrankungen
- Unterkiefererkrankungen
- Myofasziale Schmerzsyndrome
- Gelenkerkrankungen
- Kopfschmerzen
- Erkrankungen des Kiefergelenks
- Temporomandibuläres Dysfunktionssyndrom
- Kopfschmerz vom Spannungstyp
Andere Studien-ID-Nummern
- 10354421-2021/07-08
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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