Table 3.
Patient reported outcome measures
| Outcome measures | Timeline |
|---|---|
| – Oswestry Disability Index (ODI) 2.0, range 0–100 (Primary outcome) | Day 0, 28, 56, 91, 120, 154(5 months) and 278 (9 months) |
| – Low back pain intensity (mean of three Numeric Rating Scales (NRSs, range 0–10); current LBP, the worst LBP within the last 2 weeks, and usual/mean LBP within the last 2 weeks (for weekly reports during the intervention period; the wording “last 2 weeks” will be replaced by “the last week”) | Every week during treatment period and at day 154(5 months) and 278 (9 months) |
| – Roland and Morris Disability Questionnaire (RMDQ), range 0–24 | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Leg pain intensity (NRSs, range 0–10) last week | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Hours with LBP during the last 4 weeks | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Symptom-specific well-being | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Days with sick leave | Day 0, 28, 56, 91, 120, 154(5 months) and 278 (9 months) |
| – Co-interventions | Day 0, 28, 56, 91, 120, 154(5 months) and 278 (9 months) |
| – Concomitant medication | Day 0, 28, 56, 91, 120, 154(5 months) and 278 (9 months) |
| – Patients’ satisfaction | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Global perceived effect | Day 0, 56, 154(5 months) and 278 (9 months) |
| – EQ. 5D-5L | Day 0, 56, 154(5 months) and 278 (9 months) |
| – Emotional distress (Hopkins Symptom Checklist–25) | Reported at baseline |
| – Fear-avoidance beliefs Questionnaire (FABQ) | Reported at baseline |
| – Subjective health complaints (SHC) | Reported at baseline |
| – Background information | Reported at baseline |
| – Perceived treatment | Day 7, 56, 154(5 months) and 278 (9 months) |