- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04849442
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders
13. april 2021 oppdatert av: Mohamed Salah El-Sayed, Horus University
Association of Jaw Dysfunction With Neck Disability in Subjects With Chronic Cervical Spine Disorders: An Observational Study
Since TMJ and cervical pain incidence are rising and both structures are highly interrelated anatomically and functionally.
And yet no standard protocol for TMD therapy The objective of this study is to state if there is a correlation between TMD and cervical dysfunction.
To help reach a better diagnosis and a more holistic treatment.
Forty volunteers (15 male and 25 female) between the ages of 20 to 40 were recruited.
Cervical ROM was measured in all directions (rotation, flexion and extension, and sidebending) by CROM device, and a 10 cm plastic ruler marked in both centimeters and millimeters was used to measure TMJ vertical opening.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Background: The incidence of temporomandibular dysfunction has been rapidly increasing in the past years especially among women and still no definite treatment protocol and that's due to the inter lapping of anatomy and neurology of this joint with other structures all over the body.
The cervical spine dysfunction has a high incidence as well, and they are common to coexist as they are highly interrelated.
Objective: The objective of this study is to emphasize the interrelation between cervical dysfunction and TMJ dysfunction by examining the relationship between cervical spine ROM and TMJ vertical opening ROM to provide better recognition of the etiology of TMJ dysfunction thus a holistic intervention.
Materials and methods: It is a bivariate correlational research design.
Forty subjects between the age of 20 -40 years (15male/ 25females) were recruited.
Cervical ROM was measured by CROM device for all 6 cervical movements.
The TMJ vertical mouth opening was measured by a 10 cm ruler.
The CROM will be used consistent with standard clinical procedures, with 3 takes for each measurement to decrease human error.
The measurements were taken one shot.
Studietype
Observasjonsmessig
Registrering (Faktiske)
40
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Cairo, Egypt, 34518
- Outpatient clinic, Faculty of Physical Therapy, Cairo university
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 40 år (Voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The patients included in this study were recruited at the outpatient clinic of physical therapy and El Kasr El Einy Hospital from June 2019 till August 2019.
The standard procedure is that patients fill out an admission form and undergo an intake assessment.
After examination, the patient, who had a cervical dysfunction, was asked if they would be willing to undergo an assessment for this study.
Forty volunteers (15 male and 25 female) between the ages of 20 to 40 (mean 27.05 +- 3.93 )
Beskrivelse
Inclusion Criteria:
- Between the ages of 20 and 40
- Female and Male
- Suffering from a reduced cervical ROM
No reported TMJ pain
Exclusion Criteria:
- 1) Tumor (anywhere in the body)
- Recent trauma to the neck, torso or upper limb
- Active inflammation in the cervical region, upper thoraxic spine and chest or upper limb
- Recent use of orthodontics prostheses
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Cervical spine range of motion by CROM
Tidsramme: "through study completion, an average of 3 months"
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measuring the change of cervical range of motion in all directions (rotation, flexion and extension, and side bending)
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"through study completion, an average of 3 months"
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
TMJ vertical opening
Tidsramme: "through study completion, an average of 3 months"
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measuring the change of TMJ vertical opening by the second device used was a 10 cm plastic ruler marked in both centimeters and millimeters was used in the measurements, with (ICC 2,K) varied from 0.90 to 1.0, placed between the upper and lower edges of the central incisors
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"through study completion, an average of 3 months"
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Mohamed El-Sayed, Assistant lecturer, Horus University in Egypt
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2019
Primær fullføring (Faktiske)
30. august 2019
Studiet fullført (Faktiske)
30. september 2019
Datoer for studieregistrering
Først innsendt
10. april 2021
Først innsendt som oppfylte QC-kriteriene
13. april 2021
Først lagt ut (Faktiske)
19. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- msalah_bfpt
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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