연구정보 영문

Does physical activity level have an impact on long-term treatment response in temporomandibular disorders: Protocol for a prospective observational study

Status Approved

  • First Submitted Date

    2022/03/15

  • Registered Date

    2022/03/22

  • Last Updated Date

    2023/11/30

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0007107
    Unique Protocol ID CRI 21007
    Public/Brief Title Does physical activity level have an impact on long-term treatment response in temporomandibular disorders: Protocol for a prospective observational study
    Scientific Title Does physical activity level have an impact on long-term treatment response in temporomandibular disorders: Protocol for a prospective observational study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CRI 21007
    Approval Date 2021-05-06
    Institutional Review Board Name Institutional Review Board of Seoul National University Dental Hospital
    Institutional Review Board Address 101, Daehak-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 02-2072-3057
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Ji Woon Park
    Title Associate professor
    Telephone +82-2-2072-4912
    Affiliation Seoul National University
    Address Seoul National University Dental Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Young Woo Chun
    Title Resident
    Telephone +82-2-2072-4912
    Affiliation Seoul National University Dental Hospital
    Address Seoul National University Dental Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Young Woo Chun
    Title Resident
    Telephone +82-2-2072-4912
    Affiliation Seoul National University Dental Hospital
    Address Seoul National University Dental Hospital, 101, Daehak-ro, Jongno-gu, Seoul, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-07-13 Actual
    Target Number of Participant 200
    Primary Completion Date 2022-05-05 , Anticipated
    Study Completion Date 2023-05-05 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul National University Dental Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-07-13 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Seoul National University
    Organization Type University
    Project ID 860-20190102
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Temporomandibular disorders (TMD) is a disease characterized by pain and dysfunction of the masticatory muscles and temporomandibular joint. Many factors have been found to be related to the disease, however the underlying mechanism is yet to be fully elucidated. Physical activity is widely known to modulate pain intensity in various pain disorder. However, literature suggesting the association between physical activity and signs and symptoms of TMD are limited. 
    The “Physical Activity in TMD (PAT)” is a prospective cohort study on TMD patients that aims to determine how daily physical activity and sleep duration affect long-term TMD prognosis with conventional treatment. To analyze such effects, objective data on daily physical activity levels will be collected along with clinical indices including mouth opening ranges and masticatory muscle palpation responses. Well-known comorbidities of TMD will be extensively evaluated based on validated structured questionnaires on sleep quality, fatigue level, widespread pain, psychological status including depression and anxiety, autonomic symptoms, and health-related quality of life. The collected data will be analyzed according to TMD pain severity and physical activity level, and correlations among physical activity indices and long-term TMD prognosis will be investigated.
    This study is a longitudinal prospective study of adult Koreans diagnosed with TMD following standardized diagnostic procedures. Primary outcomes include physical activity levels and long-term clinical outcomes and secondary outcomes include disability from pain and related comorbidity levels. This study provides reliable data for future research and establishing clinical guidelines that will allow cause-related, patient-tailored personalized medicine for TMD.
    
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 200
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Control group with low pain level according to DC/TMD

    Cohort/Group Description

    A group of patients corresponding to Grade I and II based on the Graded Chronic Pain Scale of DC/TMD Axis II
    Cohort/
    Group 2

    Cohort/Group Label

    Control group with high pain level according to DC/TMD

    Cohort/Group Description

    A group of patients corresponding to Grade III and IV based on the Graded Chronic Pain Scale of DC/TMD Axis II
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Adult patients who are 18 years old or older with Korean nationality who visited the outpatient clinic of the Department of Oral Medicine of Seoul National University Dental Hospital with the chief complaint of pain and dysfunction of the temporomandibular joint and diagnosed as TMD
    Sampling Method
    We used a convenience sampling method in which only those who voluntarily wish to participate in the study were sampled among the patients who are eligible for the criteria
    Condition(s)/Problem(s) * (K00-K93)Diseases of the digestive system 
       (K07.6)Temporomandibular joint disorders 

    Temporomandibular Joint, Temporomandibular Disorders, Accelerometry, Actigraphy, Adult, Humans, Exercise
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    Korean adults who are 18 years old or over, diagnosed with temporomandibular joint disorder based on DC/TMD
    Exclusion Criteria
    Patients with previously diagnosed systemic musculoskeletal disorders including fibromyalgia, low back pain, rheumatoid arthritis, ankylosing spondylitis, gout, liver disease, kidney disease, uncontrolled endocrine disorder, autoimmune disease, trauma within the last 6 months, treatment history for a psychiatric disorder that may affect the study, and primary sleep disorder diagnosis
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Amount of physical activity and sleep duration 
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Primary Outcome(s) 2
    Outcome
    Amount of comfortable mouth opening
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Primary Outcome(s) 3
    Outcome
    Amount of maximum mouth opening
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Primary Outcome(s) 4
    Outcome
    Muscle tenderness on palpation
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Primary Outcome(s) 5
    Outcome
    Joint capsule tenderness on palpation
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 1
    Outcome
    International Physical Activity Questionnaire (IPAQ)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 2
    Outcome
    Tampa Scale of Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 3
    Outcome
    Pittsburgh Sleep Quality Index (PSQI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 4
    Outcome
    Epworth Sleepiness Scale (ESS)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 5
    Outcome
    Fatigue Assessment Instrument (FAI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 6
    Outcome
    Insomnia Severity Index (ISI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 7
    Outcome
    Morningness-eveningness questionnaire (MEQ)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 8
    Outcome
    Symptom severity (SS) scale
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 9
    Outcome
    widespread pain index (WPI) 
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 10
    Outcome
    Fibromyalgia Impact Questionnaire (FIQ)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 11
    Outcome
    Symptom Checklist-90-Revised (SCL-90-R)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 12
    Outcome
    Beck Depression Index (BDI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 13
    Outcome
    Beck Anxiety Index (BAI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 14
    Outcome
    Pain Catastrophizing Scale (PCS)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 15
    Outcome
    Central Sensitization Inventory (CSI)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 16
    Outcome
    Pennebaker Index of Limbic Languidness (PILL)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 17
    Outcome
    Perceived Stress Scale (PSS)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 18
    Outcome
    Short Form 36
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 19
    Outcome
    Composite Autonomic Symptom Score 31 (COMPASS 31)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 20
    Outcome
    McGill Pain Questionnaire (MPQ)
    Timepoint
    patient's first visit and at 6- and 12-month post-treatment
    Secondary Outcome(s) 21
    Outcome
    Hematologic indices of systemic inflammation, including red blood cell (RBC), hsCRP, erythrocyte sedimentation rate (ESR), platelet-to-lymphocyte ratio (PLR), neutrophil lymphocyte ratio (NLR), and derived neutrophil lymphocyte ratio (dNLR) 
    Timepoint
    patient's first visit
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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