Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

NCT04867044 | Completed

• 1 other identifier: 2017-KAEK-189_2021.03.10_17
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Temporomandibular Disorder; Fibromyalgia

Keywords

fibromiyalgia syndrome; Temporomandibular Disorders

Outcome Measures

Primary Outcomes (3)

• DCTMD: AI Axis I Pain Screener

  TMD Pain Screener which is a simple, reliable, and valid self-report instrument used to assess for the presence of any pain-related TMD, with sensitivity and specificity ≥ 0.95 which is recommended for all patients in any clinical setting. A positive screen is followed by further evaluation to arrive at the specific TMD pain-related diagnoses.

  0 DAY

• DCTMD: AI Axis I Symptom questionnaire

  Symptom questionnaire which assess pain characteristics as well as history of jaw noise, jaw locking, and headache.

  0 DAY

• DCTMD: AI Axis I Clinical Examination Form

  Clinical Examination Form- The clinical examination includes provocation tests for TMJ arthralgia of pain with any jaw movement (ie, opening, lateral, and protrusive) and TMJ palpation. For myalgia, the tests include pain with opening jaw movements and palpation of the temporalis and masseter muscles.

  0 DAY

Secondary Outcomes (5)

• DCTMD: AI Axis II-Pain Drawing

  0 DAY

• DCTMD: AI Axis II-Graded Chronic Pain (version 2)

  0 DAY

• DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)

  0 DAY

• DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)

  0 DAY

• DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)

  0 DAY

Study Arms (2)

STUDY GROUP

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

Other: STUDY

CONTROL GROUP

healthy women volunteers

Other: Control

Interventions

STUDY OTHER

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

Also known as: Fibromiyalgia Patient

STUDY GROUP

Control OTHER

healthy woman volunteers

Also known as: healthy participant

CONTROL GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Our study consists of 300 female participants aged between 18 and 65 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients with temporomandibular region surgery
• Congenital teporomandibular joint pathologies
• Previous temporomandibular region trauma were excluded from the study.

Sponsors & Collaborators

• Yerkoy State Hospital: lead

Study Sites (2)

Basak Cigdem karacay

Yozgat, Yerkoy, 66900, Turkey (Türkiye)

Location

Basak CigdemKaracay

Yozgat, Yerkoy, 66900, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27539739 BACKGROUND

• 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.

  PMID: 27050847 BACKGROUND

• 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.

  PMID: 23461261 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Fibromyalgia

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Spesialist

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 30, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 27, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

TU (2)