Pre-randomisation
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Consultation with clinician
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Inclusion/exclusion criteria; informed consent; type and date of consultation
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Baseline assesment
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Inclusion/exclusion criteria confirmed; date enrolled in the study; demographic data;
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Episode characteristics: duration of current symptoms, number of previous episode, presence of leg pain, days of reduced activity from back pain, feelings of depression, perceived risk of pain persistence, compensation status, work status, income and health insurance;
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Outcome variables: baseline pain intensity visual analogue scale, global perceived change scale (GPC), sleep quality (item 6 Pittsburg Sleep Quality Index), Patient Specific Functional Scale (PSFS), Roland Morris disability questionnaire (RMDQ), Credibility Expectancy Questionnaire, Short Form 12 (SF12v2)
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Week 1
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Day 1 to 7
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Daily pain rating scale and daily medication intake
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Day 7
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Adverse events, if participant returned to clinician and if offered rescue medication, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ
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Week 2
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Day 8 to 14
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Daily pain rating scale and daily medication intake if not recovered prior
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Day 14
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Adverse events, if participant returned to clinician and if offered rescue medication, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ
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Week 4
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Day 15 to 28
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Daily pain rating scale and daily medication intake if not recovered prior
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Day 28
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Adverse events, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ, SF12v2, Hours absent from work per week (weeks 1–4), additional treatments used (weeks 1–4), Brief Adherence rating Scale.
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Week 12
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Day 29 to 84
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Daily pain rating scale until recovery or day 84 if not recovered prior
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Day 84 |
Adverse events, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ, SF12v2, hours absent from work per week (weeks 5–12), additional treatments used (weeks 5–12), satisfaction with treatment, treatment blinding questionnaire. |