Table 2.
Time points and the assessed dimensions at the time points
| Study period | Enrollment | Allocation | Post-treatment | Follow-up | ||
|---|---|---|---|---|---|---|
| Timepoint (week) | − 1 | 0 | 4 | 8 | 12 | 24 |
| Enrollment | ||||||
| Eligibility screening | X | |||||
| Informed consent | X | |||||
| Demographic characteristics | X | |||||
| Medical history | X | |||||
| Laboratory tests | X | X | X | x | ||
| 2-lead electrocardiograms | X | x | ||||
| Randomization | X | |||||
| Allocation | X | |||||
| Interventions | ||||||
| Ba-Duan-Jin + placebo | -----------------------------------------------------------> | |||||
| Pregabalin + wellness education + muscle relaxation exercise | -----------------------------------------------------------> | |||||
| Assessments | ||||||
| Pain VAS | X | X | X | X | X | X |
| FIQR | X | X | X | X | X | |
| MFI-20 | X | X | X | X | X | |
| PSQI | X | X | X | X | X | |
| BDI-II | X | X | X | X | X | |
| PSS | X | X | X | X | X | |
| SF-36 | X | X | X | X | X | |
| PGIC | X | X | ||||
| SSS | X | X | X | X | X | |
| 50% Reduction for pain | X | X | X | X | ||
| Adverse events | X | X | X | |||
VAS Visual Analogue Scale, FIQR Revised Fibromyalgia Impact Questionnaire, MFI-20 Multidimensional Fatigue Inventory-20, PSQI Pittsburgh Sleep Quality Index, BDI Beck II Depression Inventory, PSS Perceived Stress Scale, SF-36 Short Form-36 Health Status Questionnaire, SSS Symptom Severity Scale