Status Approved
First Submitted Date
2022/03/15
Registered Date
2022/03/22
Last Updated Date
2023/11/30
1. Background
CRIS Registration Number |
KCT0007107 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Seoul National University |
Organization Type | University |
Project ID | 860-20190102 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul National University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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
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 |
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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)
Type of Primary Outcome | Not applicable | |
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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 |
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Secondary Outcome(s) 14 | ||
Outcome | Pain Catastrophizing Scale (PCS) |
|
Timepoint | patient's first visit and at 6- and 12-month post-treatment |
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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 |
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Secondary Outcome(s) 17 | ||
Outcome | Perceived Stress Scale (PSS) |
|
Timepoint | patient's first visit and at 6- and 12-month post-treatment |
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Secondary Outcome(s) 18 | ||
Outcome | Short Form 36 |
|
Timepoint | patient's first visit and at 6- and 12-month post-treatment |
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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 |
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Secondary Outcome(s) 20 | ||
Outcome | McGill Pain Questionnaire (MPQ) |
|
Timepoint | patient's first visit and at 6- and 12-month post-treatment |
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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) |
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Timepoint | patient's first visit |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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