- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07642609
To Investigate the Effect of Condylar Remodeling Exercises on Proprioception of Neck and Temporomandibular Joint in Cranio-cervico-mandibular Malalignment.
8. června 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: walaa Mohsen Mohamed, Doctoral degree
- Telefonní číslo: 01004174717
- E-mail: wala.mohamed@must.edu.eg
Studijní místa
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Giza, Egypt
- Misr University for Science and Technology
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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:
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Aktivní komparátor: Control group (postural correction Exercise only)
Control group: include 20 subjects will receive postural correction Exercise only
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Kendall exercises were performed as follows:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Temporomandibular joint position sense (TMJPS)
Časové okno: 24 hours from first and last session
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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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
20. června 2026
Primární dokončení (Odhadovaný)
20. září 2026
Dokončení studie (Odhadovaný)
20. října 2026
Termíny zápisu do studia
První předloženo
8. června 2026
První předloženo, které splnilo kritéria kontroly kvality
8. června 2026
První zveřejněno (Aktuální)
11. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Condylar Remodeling Exercises
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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