Table 2.
Schedule for assessment
| Outcome measures | Screening | Baseline | Treatment (weeks 1–8) | Follow-up (weeks 9–16) | ||
|---|---|---|---|---|---|---|
| Week 4 | Week 8 | Week 12 | Week 16 | |||
| VAS for lower back pain | ◎ | ◎ | ◎ | ◎ | ◎ | ◎ |
| VAS for radiating pain | ◎ | ◎ | ◎ | ◎ | ◎ | |
| ODI | ◎ | ◎ | ◎ | ◎ | ◎ | |
| RMDQ | ◎ | ◎ | ◎ | ◎ | ◎ | |
| EQ-5D-5 L | ◎ | ◎ | ◎ | ◎ | ◎ | |
| GPE | ◎ | ◎ | ◎ | ◎ | ||
| Assessment of binding | ◎ | |||||
| Adverse eventsa | ◎ | ◎ | ◎ | ◎ | ◎ | |
aAdverse event will be monitored throughout the study period
VAS visual analogue scale, ODI Oswestry Disability Index, RMDQ Roland-Morris disability questionnaire, EQ-5D-5 L EuroQol 5 Dimensions 5 Levels, GPE global perceived effect