Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome

July 11, 2022 updated by: Başak Çiğdem Karaçay, Yerkoy State Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yerkoy
      • Yozgat, Yerkoy, Turkey, 66900
        • Basak Cigdem karacay
      • Yozgat, Yerkoy, Turkey, 66900
        • Basak CigdemKaracay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
STUDY GROUP
patient diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
Other: STUDY
One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
Other Names:
  • Fibromiyalgia Patient
CONTROL GROUP
healthy women volunteers
Other: Control
healthy woman volunteers
Other Names:
  • healthy participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCTMD: AI Axis I Pain Screener
Time Frame: 0 DAY
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
Time Frame: 0 DAY
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
Time Frame: 0 DAY
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCTMD: AI Axis II-Pain Drawing
Time Frame: 0 DAY
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
DCTMD: AI Axis II-Graded Chronic Pain (version 2)
Time Frame: 0 DAY
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
DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8)
Time Frame: 0 DAY
Jaw Functional Limitation Scale-8 (JFLS-8) which assesses global limitations across mastication, jaw mobility, and verbal and emotional expression
0 DAY
DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4)
Time Frame: 0 DAY
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
DCTMD: AI Axis II- Oral Behaviors Checklist (OBC)
Time Frame: 0 DAY
Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.
0 DAY

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yerkoy State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-KAEK-189_2021.03.10_17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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