Background
Objectives
Methods and design
Participants, interventions, and outcomes
Study design
Participants and eligibility criteria
Interventions
Recruitment of cases
Patient grouping
Pain disability level evaluated with graded chronic pain scale (GCPS) of DC/TMD axis II
Amount of time counted as moderate to vigorous physical activity (MVPA)
Study outcomes
3.1.6.1. Primary outcome measures: clinical outcomes listed below will be gathered at the participant’s first visit (baseline) and at 6- and 12-month post-treatment.
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Amount of physical activity and sleep duration objectively measured using ActiGraph wGT3X-BT (ActiGraph, Florida, USA), a validated 3-axis accelerometer that includes ambient light sensors. Actigraphy is a method to monitor the cycles of rest and activity, which does not involve any invasive procedures. The movements of the accelerometer and light exposure can be continually recorded with a watch-like device worn on the wrist to objectively determine the amount of physical activity and sleep duration of a participant. Despite its limitations in measuring and staging sleep, actigraphy data provides real-life information on both the objective amount of physical activity and sleep by allowing the participant to maintain normal routines in his or her natural environment. Physical activity is measured at baseline only. (Fig. 1)
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Amount of comfortable mouth opening [12] the participant will be asked to open his or her mouth as wide as possible while remaining pain-free. If the participant is already experiencing pain, open as wide as possible without increasing current pain. Interincisal distance between the maxillary and mandibular reference teeth will be measured.
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Amount of maximum mouth opening [12] the participant will be asked to open as wide as possible, even if it is painful. Interincisal distance between the maxillary and mandibular reference teeth will be measured.
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Muscle tenderness on palpation [12] 12 masticatory muscle areas will be palpated on both sides including posterior, middle, and inferior temporalis muscle area and origin, body, and insertion of the masseter muscle with 1 kg of pressure.
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Joint capsule tenderness on palpation [12] 6 areas of TMJ will be palpated on both sides including the posterior, superior, and lateral parts of the capsule with 0.5 kg of pressure in a passive state. When palpation elicits subjective pain, the response will be recorded as positive. Joint noises are verified through palpation.
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Subjective pain intensity participant reported pain intensity based on a 0–10 numeric rating scale (NRS).
Secondary outcomes: comorbidity and systemic inflammation levels
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Series of validated structured questionnaires to assess comorbidity levels (Table 1)
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Hematologic indices of systemic inflammation: red blood cell (RBC) levels showed significant correlations with pain intensity before treatment, comfortable mouth opening, pain on palpation of cervical muscles, and mouth opening range at 6 months after treatment [33]; hsCRP and erythrocyte sedimentation rate (ESR) are non-specific markers of inflammatory activity used in patients of rheumatoid arthritis or spondyloarthritis [34]; platelet-to-lymphocyte ratio (PLR), neutrophil–lymphocyte ratio (NLR), and derived neutrophil–lymphocyte ratio (dNLR) are widely used inflammatory biomarkers showing significant correlation with disease activity and mortality [35‐38].
Section | Questionnaire | Description |
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Physical activity | International physical activity questionnaire (IPAQ) [13] | assess physical activity level based on self-report |
Tampa scale of kinesiophobia for temporomandibular disorders | assess the severity of exaggerated, incoherent, and debilitating fear of movement and activity | |
Sleep disturbance and fatigue | Pittsburgh sleep quality index (PSQI) [16] | assess the quality of sleep over a one-month period |
Epworth sleepiness scale (ESS) [17] | assess the daytime sleepiness of the patients | |
Fatigue assessment instrument (FAI) [18] | assess fatigue and distinguish normal fatigue from fatigue-related medical disorders | |
Insomnia severity index (ISI) [19] | assess the severity of insomnia | |
Morningness−eveningness questionnaire (MEQ) [20] | investigate morningness and eveningness of patients as to when the subject would prefer to start sleep or wake up, rather than when he or she actually does | |
Widespread pain | Symptom severity (SS) scale [21] | diagnose fibromyalgia in patients based on the adapted 2010 American College of Rheumatology fibromyalgia survey criteria. And also, to assess the severity of widespread body pain and centralized pain characteristics |
Widespread pain index (WPI) [21] | ||
Fibromyalgia impact questionnaire (FIQ) [22] | measure status, progress and outcomes of fibromyalgia-like widespread pain by assessing physical performance, work condition, depression, anxiety, tiredness in the morning, pain, rigidity, fatigue, and well-being over the one-week period | |
Psychologic disturbance | Symptom checklist-90-revised (SCL-90-R) [23] | evaluate psychological problems and psychotic symptoms |
Beck depression index (BDI) [24] | evaluate presence of pathological levels of depression over the recent one-week period | |
Beck anxiety index (BAI) [25] | assess the severity of physical and cognitive symptoms originating in anxiety over the recent one-week period | |
Pain catastrophizing scale (PCS) [26] | assess the patient’s tendency to exaggerate the threat of a pain stimulus and to feel helpless | |
Central sensitization inventory (CSI) [27] | identify patients who have symptoms that may be related to central sensitization or central sensitivity syndromes | |
Pennebaker Index of Limbic Languidness (PILL) [28] | measure an individual’s tendency to notice an array of physical symptoms and sensations | |
Perceived stress scale (PSS) [29] | measure nonspecific perceived stress | |
General health | Short form 36 (SF-36) [30] | evaluate difficulties in various activities including physical, social, and usual role, bodily pain, mental health in general, vitality, and general perceptions of health |
Composite autonomic symptom score 31 (COMPASS 31) [31] | score autonomic symptom severity in domains including orthostatic intolerance, vasomotor, secretomotor, gastrointestinal, bladder, and pupillomotor | |
Short form McGill pain questionnaire (MPQ) [32] | document the quality and intensity of pain experienced by the patient |