Prevalence of Temporomandibular Disorders in Patients With Fibromyalgia Syndrome
- Conditions
- Temporomandibular DisorderFibromyalgia
- Interventions
- Other: ControlOther: STUDY
- Registration Number
- NCT04867044
- Lead Sponsor
- Yerkoy State Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- One hundred fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
- One hundred fifty womanhealthy volunteers
- Patients with temporomandibular region surgery
- Congenital teporomandibular joint pathologies
- Previous temporomandibular region trauma were excluded from the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CONTROL GROUP Control healthy women volunteers STUDY GROUP STUDY patient diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
- Primary Outcome Measures
Name Time Method DCTMD: AI Axis I Pain Screener 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.
DCTMD: AI Axis I Symptom questionnaire 0 DAY Symptom questionnaire which assess pain characteristics as well as history of jaw noise, jaw locking, and headache.
DCTMD: AI Axis I Clinical Examination Form 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.
- Secondary Outcome Measures
Name Time Method DCTMD: AI Axis II- Oral Behaviors Checklist (OBC) 0 DAY Oral Behaviors Checklist (OBC), which assesses the frequency of oral parafunctional behaviors.
DCTMD: AI Axis II-Pain Drawing 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
DCTMD: AI Axis II-Graded Chronic Pain (version 2) 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
DCTMD: AI Axis II-Jaw Functional Limitation Scale-8 (JFLS-8) 0 DAY Jaw Functional Limitation Scale-8 (JFLS-8) which assesses global limitations across mastication, jaw mobility, and verbal and emotional expression
DCTMD: AI Axis II-Patient Health Questionnaire (PHQ-4) 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
Trial Locations
- Locations (2)
Basak Cigdem karacay
🇹🇷Yozgat, Yerkoy, Turkey
Basak CigdemKaracay
🇹🇷Yozgat, Yerkoy, Turkey