Clinical trial NCT04867044: Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome
Official title: Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorder
Fibromyalgia
Keywords: fibromiyalgia syndrome
Temporomandibular Disorders
Lead sponsor: Yerkoy State Hospital
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Our study consists of 300 female participants aged between 18 and 65 years who applied to the physical therapy and rehabilitation outpatient clinic.. One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria and 150 healthy woman volunteers were included.Because fibromyalgia is a disease that mostly affects women, we designed our study so that all participants were women.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: DCTMD: AI Axis I Pain Screener
timeFrame: 0 DAY
measure: DCTMD: AI Axis I Symptom questionnaire
timeFrame: 0 DAY
measure: DCTMD: AI Axis I Clinical Examination Form
timeFrame: 0 DAY
Secondary outcomes:
measure: DCTMD: AI Axis II-Pain Drawing
timeFrame: 0 DAY
measure: DCTMD: AI Axis II-Graded Chronic Pain (version 2)
timeFrame: 0 DAY
measure: DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)
timeFrame: 0 DAY
measure: DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)
timeFrame: 0 DAY
measure: DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)
timeFrame: 0 DAY
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Basak Cigdem karacay
state: Yerkoy
city: Yozgat
country: Turkey
facility: Basak CigdemKaracay
state: Yerkoy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.