Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

NCT ID: NCT04867044

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-08-27

Brief Summary

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One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included.Demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments (DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: Temporomandibular Disorders (TMD) Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4), Oral Behaviors Checklist will be applied within the scope of Axis II.

Detailed Description

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In our study, the investigators aim to compare the frequency of temporomandibular disorders between healthy female participants and female patients diagnosed with fibromyalgia.

Our study will consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic between May 2021 and August 2021. This case-control study will conducted according to the Declaration of Helsinki. Participants gave written voluntary consent and enrolled in this case-control study. One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers will be included. Patients with temporomandibular region surgery, congenital teporomandibular joint pathologies, and previous temporomandibular region trauma were will be excluded from the study. Because fibromyalgia is a disease that mostly affects women, the investigators designed our study so that all participants were women. In addition, demographic data (age, gender, height, weight, marital status, education level) and duration of fibromyalgia diagnosis will be recorded. Patients will be evaluated according to the Diagnostic Criteria for Temporomandibular Disorders: Assessment Instruments ( DCTMD: AI ). Patients will be evaluated by Diagnostic Criteria for Temporomandibular Disorders: TMD Pain Screener, Symptom questionnaire, Clinical Examination Form from Assessment Instruments Axis I. Pain Drawing, Graded Chronic Pain (version 2), Jaw Functional Limitation Scale-8 (JFLS-8), Patient Health Questionnaire (PHQ-4),Oral Behaviors Checklist will be applied within the scope of Axis II.

Conditions

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Temporomandibular Disorder Fibromyalgia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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STUDY GROUP

patient diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria

STUDY

Intervention Type OTHER

One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria

CONTROL GROUP

healthy women volunteers

Control

Intervention Type OTHER

healthy woman volunteers

Interventions

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STUDY

One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria

Intervention Type OTHER

Control

healthy woman volunteers

Intervention Type OTHER

Other Intervention Names

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Fibromiyalgia Patient healthy participant

Eligibility Criteria

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Inclusion Criteria

* One hundred fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
* One hundred fifty womanhealthy volunteers

Exclusion Criteria

* Patients with temporomandibular region surgery
* Congenital teporomandibular joint pathologies
* Previous temporomandibular region trauma were excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yerkoy State Hospital

OTHER

Sponsor Role lead

Responsible Party

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Başak Çiğdem Karaçay

Spesialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Basak Cigdem karacay

Yozgat, Yerkoy, Turkey (Türkiye)

Site Status

Basak CigdemKaracay

Yozgat, Yerkoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Moreno-Fernandez AM, Jimenez-Castellanos E, Iglesias-Linares A, Bueso-Madrid D, Fernandez-Rodriguez A, de Miguel M. Fibromyalgia syndrome and temporomandibular disorders with muscular pain. A review. Mod Rheumatol. 2017 Mar;27(2):210-216. doi: 10.1080/14397595.2016.1221788. Epub 2017 Feb 1.

Reference Type BACKGROUND
PMID: 27539739 (View on PubMed)

Fujarra FJ, Kaziyama HH, Siqueira SR, Yeng LT, Camparis CM, Teixeira MJ, Siqueira JT. Temporomandibular disorders in fibromyalgia patients: are there different pain onset? Arq Neuropsiquiatr. 2016 Mar;74(3):195-200. doi: 10.1590/0004-282X20160017.

Reference Type BACKGROUND
PMID: 27050847 (View on PubMed)

Pimentel MJ, Gui MS, Martins de Aquino LM, Rizzatti-Barbosa CM. Features of temporomandibular disorders in fibromyalgia syndrome. Cranio. 2013 Jan;31(1):40-5. doi: 10.1179/crn.2013.006.

Reference Type BACKGROUND
PMID: 23461261 (View on PubMed)

Other Identifiers

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2017-KAEK-189_2021.03.10_17

Identifier Type: -

Identifier Source: org_study_id

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