- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05058573
Effcet of Temporomandibular Joint Disorder Relaxation and Myofacial Relaxation Techniques on Tension Headache
6 novembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Alanya
-
Antalya, Alanya, Turquie
- Alanyaaku
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
|
Expérimental: 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
|
|
Expérimental: Control group (n=22)
only medication treatment will be applied
|
Control group will be received only medical treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cervikal region range of motion measurement
Délai: "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
Délai: "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
Délai: "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
Délai: "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
Délai: "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
Délai: "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
Délai: "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"
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Hanifegül Taşkıran, Prof. Dr, Istanbul Aydın University
- Directeur d'études: Mustafa Zafer DEMİRTAŞ, MD, Alanya Alaaddin Keykubat University
- Directeur d'études: Ertan KARAÇAY, MD, Alanya Alaaddin Keykubat University
- Directeur d'études: Ahmet ÖZŞİMŞEK, PHD MD, Alanya Alaaddin Keykubat University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 avril 2021
Achèvement primaire (Réel)
10 juin 2021
Achèvement de l'étude (Anticipé)
15 novembre 2021
Dates d'inscription aux études
Première soumission
9 septembre 2021
Première soumission répondant aux critères de contrôle qualité
17 septembre 2021
Première publication (Réel)
27 septembre 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 novembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 novembre 2021
Dernière vérification
1 novembre 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- La douleur
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies musculaires
- Maladies stomatognathiques
- Céphalées, primaires
- Troubles de la tête
- Maladies de la mâchoire
- Troubles craniomandibulaires
- Maladies mandibulaires
- Syndromes de douleur myofasciale
- Maladies articulaires
- Mal de tête
- Troubles de l'articulation temporo-mandibulaire
- Syndrome de dysfonctionnement de l'articulation temporo-mandibulaire
- Céphalée de tension
Autres numéros d'identification d'étude
- 10354421-2021/07-08
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .