Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867044
• Other study ID #: 2017-KAEK-189_2021.03.10_17
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: August 27, 2021

Study information

• Verified date: July 2022
• Source: Yerkoy State Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 27, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Fibromyalgia
• Myofascial Pain Syndromes
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• STUDY
One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
• Control
healthy woman volunteers

Locations

Country	Name	City	State
Turkey	Basak Cigdem karacay	Yozgat	Yerkoy
Turkey	Basak CigdemKaracay	Yozgat	Yerkoy

Sponsors (1)

Lead Sponsor	Collaborator
Yerkoy State Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Moreno-Fernández AM, Jiménez-Castellanos E, Iglesias-Linares A, Bueso-Madrid D, Fernández-Rodríguez 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	DCTMD: AI Axis II-Pain Drawing	Pain Drawing-pain drawing of the head, jaw, and body, and it allows the patient to report the location of all pain complaints	0 DAY
Secondary	DCTMD: AI Axis II-Graded Chronic Pain (version 2)	Graded Chronic Pain (version 2) is a short, reliable, and valid instrument that assesses pain intensity and pain-related disability.10 The two GCPS subscales are: Characteristic Pain Intensity (CPI), which reliably measures pain intensity, with = 50/100 considered "high intensity," and the pain-disability rating, which is based on number of days that pain interferes with activity and on extent of interference with social, work, or usual daily activities	0 DAY
Secondary	DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)	Jaw Functional Limitation Scale-8 (JFLS-8) which assesses global limitations across mastication, jaw mobility, and verbal and emotional expression	0 DAY
Secondary	DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)	Patient Health Questionnaire (PHQ-4) is a short, reliable, and valid screening instrument for detecting "psychological distress" due to anxiety and/or depression in patients in any clinical setting.A cutoff of > 6, suggesting moderate psychological stress, should be interpreted as warranting observation, while a cutoff of > 9, suggesting severe psychological distress, should be interpreted as warranting either further assessment or referral	0 DAY
Secondary	DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)	Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.	0 DAY