- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07642609
To Investigate the Effect of Condylar Remodeling Exercises on Proprioception of Neck and Temporomandibular Joint in Cranio-cervico-mandibular Malalignment.
8 juin 2026 mis à jour par: Walaa Mohsen Mohammed, Cairo University
Effect of Condylar Remodeling Exercises on Proprioception of Neck and Temporomandibular Joint in Cranio-cervico-mandibular Malalignment: A Randomized, Double-blind, Controlled Trial
Cranio-cervico-mandibular (CCM) malalignment is associated with forward head posture (FHP) and tempromandibular joint (TMJ) disorders and affects masticatory muscles.
Patients who present with dysfunctions of CCM malalignment can be treated effectively by a physical therapist who has specialized skills and experiences.
A temporomandibular joint exercise developed by Rocabado called "Condylar remodeling exercises" considered as a new method for treatment of such cases.
Those exercises stimulate mechanoreceptors that converts mechanical energy of physical deformation into action nerve potential yielding proprioceptive information, detecting change and rate of change, as opposed to steady state conditions.
This input was analyzed in the central nervous system for joint position and movement influences muscle tone, motor execution programes and kinesthetic awareness around temporomandibular joint protecting joint from damage and helps to restore appropriate balance of synergistic and antagonistic forces.
Although condylar remodeling exercises has been used in clinical practice, limited evidence exists to support such a treatment approach.
So, the current study will conduct to investigate the effect of Condylar Remodeling Exercises on proprioception of neck and TMJ in CCM malalignment
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
To determine if there is an effect for the effect of Condylar Remodeling Exercises on proprioception of neck and TMJ in CCM malalignment.
40 of both sexes will participate in this study.
Assessment of all participants will be carried out before and after the treatment program.
Outcome measures will include assessment of neck proprioception, Temporomandibular joint position sense, cranio-vertebral angle, active pain-free mouth opening, pain assessment.A total of 40 subjects of both sexes having CCM malalignment will be recruited in this study.
They will be randomly assigned to one of the following groups: Study group include 20 subjects will receive Condylar remodeling exercises in addition to postural correction Exercise, Control group: include 20 subjects will receive postural correction Exercise only.
All subjects in both groups will receive the exercise program 3 days a week for four weeks.
Type d'étude
Interventionnel
Inscription (Estimé)
40
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.
Coordonnées de l'étude
- Nom: walaa Mohsen Mohamed, Doctoral degree
- Numéro de téléphone: 01004174717
- E-mail: wala.mohamed@must.edu.eg
Lieux d'étude
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-
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Giza, Egypte
- Misr University for Science and Technology
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-
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
- Adulte
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
The participants will be excluded if they:
- The patient's ages from 18 to 40 years
- having TMD symptoms sustained for at least twelve weeks duration established by expert physician or orthopaedician.
- having forward head posture with CVA < 53o.
- mouth opening < 25mm.
- Pain level greater than 20 mm and less than 80 mm on Numeric Rating Scale (NRS).
Exclusion Criteria:
- (1) TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic joint diseases including rheumatoid arthritis and osteoporosis, congenital conditions orofacial paralysis; (5) recent dental work or TMJ surgery; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia;(8) Recent infections affecting head and neck (within the last six months) e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g.dentures, braces, bite appliances altered or fitted within the previous 12 weeks prior to the commencement of this study; (10) Patients who underwent any physical therapy treatment within the last 2 weeks before the trial; (11) Internal derangement, including disc displacement with or without reduction
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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Study group (Condylar remodeling exercises in addition to postural correction Exercise
Study group include 20 subjects will receive Condylar remodeling exercises in addition to postural correction Exercise,
|
A temporomandibular joint exercise developed by Rocabado called "Condylar remodeling exercises" considered as a new method for treatment of such cases.
Those exercises stimulate mechanoreceptors that converts mechanical energy of physical deformation into action nerve potential yielding proprioceptive information, detecting change and rate of change, as opposed to steady state conditions.
This input was analysed in the central nervous system for joint position and movement influences muscle tone, motor execution programmes and kinaesthetic awareness around temporomandibular joint protecting joint from damage and helps to restore appropriate balance of synergistic and antagonistic forces.
Although condaylar remodling exercises has been used in clinical practice, limited evidence exists to support such a treatment approach
Kendall exercises were performed as follows:
|
|
Comparateur actif: Control group (postural correction Exercise only)
Control group: include 20 subjects will receive postural correction Exercise only
|
Kendall exercises were performed as follows:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Temporomandibular joint position sense (TMJPS)
Délai: 24 hours from first and last session
|
For the TMJPS measurement, a 6 mm-thick wooden reference stick and 9 wooden test sticks from 4 mm to 8 mmin thickness (increment 0.5 mm) will be used.
First, the participants will be asked to sense the position by biting the 6 mm thick reference test stick with their front teeth for 1 minute.
Then, they will be asked to randomly bite each of the 9 test sticks and compare each of them with the 6 mm reference test stick.
Each of the test sticks will be administered in a random order 5 times (45 tests in total).
The participants will be asked how thick they felt compared to the reference stick that they have bitten down on and indicated their answers as "thinner", "thicker" or "equal".
During the test, the participant's eyes will be closed, and the answers give about the stick thicknesses will be recorded as true (1 point) or false (0 points).
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24 hours from first and last session
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Active pain-free mouth opening
Délai: 24 hours from first and last session
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In a supine position, participants will be asked to 'open the mouth as wide as possible without causing pain'.
At the end position of pain-free mouth opening, the distance between upper-lower central incisors was measured in millimeters.
The mean of three trials was calculated and used for the main analysis.
Active pain-free mouth opening will be assessed pre-intervention, 48 h after the last treatment (post-intervention) and at 12-week follow up period.
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24 hours from first and last session
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Yuzbasioglu U, Kaynak BA, Tas S. Assessment of Cervical Joint Position Sense and Head Posture in Individuals With Myogenic Temporomandibular Dysfunctions and Identifying Related Factors: A Case-Control Study. J Oral Rehabil. 2025 Feb;52(2):160-168. doi: 10.1111/joor.13885. Epub 2024 Oct 20.
- Dinsdale A, Thomas L, Forbes R, Treleaven J. Is proprioception affected in those with persistent intra-articular temporomandibular disorders? A cross-sectional study exploring joint position sense and force sense of the jaw. Musculoskelet Sci Pract. 2024 Feb;69:102904. doi: 10.1016/j.msksp.2023.102904. Epub 2023 Dec 29.
- Micoogullari M, Yuksel I, Angin S. Effect of pain on cranio-cervico-mandibular function and postural stability in people with temporomandibular joint disorders. Korean J Pain. 2024 Apr 1;37(2):164-177. doi: 10.3344/kjp.23301.
- Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Cranio. 2006 Oct;24(4):283-91. doi: 10.1179/crn.2006.044.
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 (Estimé)
20 juin 2026
Achèvement primaire (Estimé)
20 septembre 2026
Achèvement de l'étude (Estimé)
20 octobre 2026
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
8 juin 2026
Première publication (Réel)
11 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- Condylar Remodeling Exercises
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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
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