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) |