Table 1 Participants schedule
Study period | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
Time point | Screening | Enrollment, Allocation | Active treatment after allocation | Follow-up | |||||||
Week − 1 | Week 0 (Baseline) | Week | Week | Week | Week | Week | Week | Week | Week | Week | |
1 | 2 | 3 | 4 | 5 | 6 | 9 | 13 | 25 | |||
Visit 1 | Visit 2 | Visit 2, 3 | Visit 4, 5 | Visit 6,7 | Visit 8,9 | Visit 10,11 | Visit 12 | Visit 13 | Visit 14 | Visit 15 | |
Window period | ±3 | ±3 | ±3 | ±3 | ±3 | ±3 | ±14 | ±14 | ±14 | ||
Enrollment | |||||||||||
Eligibility Screening | ○ | ○ | |||||||||
Written informed consent | ○ | ||||||||||
Vital signs | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
Sociodemographic Characteristics, Medical History (e.g. neck pain, medication history) | ○ | ||||||||||
RDC/TMD test & analysis | ○ | ||||||||||
pattern Identification | ○ | ||||||||||
Laboratory test | ○ | ○ | |||||||||
Randomised Allocation | ○ | ||||||||||
Interventions | |||||||||||
Treatment in JHG002 (experimental group) | ← 2 times/week → | ||||||||||
Treatment in TENS (active control group) | ← 2 times/week → | ||||||||||
Assessments | |||||||||||
Symptoms and change in medicine | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ||
NRS of TMJ pain/Bothersomeness | ← Every visit → | ○ | ○ | ○ | ○ | ||||||
VAS of TMJ pain | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
K-BDI-II | ○ | ○ | ○ | ○ | |||||||
JFLS | ○ | ○ | ○ | ○ | |||||||
TMJ range of motion (maximum mouth opening, mandibular excursive movement) | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | ○ | |
Compliance | ○ | ○ | ○ | ○ | ○ | ||||||
PGIC | ○ | ○ | |||||||||
EQ-5D-5 L | ○ | ○ | ○ | ○ | ○ | ○ | |||||
SF-12 | ○ | ○ | ○ | ○ | ○ | ○ | |||||
Credibility and expectancy | ○ | ||||||||||
Adverse events | ← Every visit → | ○ | ○ | ○ | ○ | ||||||