Skip to main content

Table 1 Data collection and follow up stages

From: PACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan

Time point

Data captured

Pre-randomisation

 

Consultation with clinician

Inclusion/exclusion criteria; informed consent; type and date of consultation

Baseline assesment

Inclusion/exclusion criteria confirmed; date enrolled in the study; demographic data;

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;

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)

Week 1

 

Day 1 to 7

Daily pain rating scale and daily medication intake

Day 7

Adverse events, if participant returned to clinician and if offered rescue medication, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ

Week 2

 

Day 8 to 14

Daily pain rating scale and daily medication intake if not recovered prior

Day 14

Adverse events, if participant returned to clinician and if offered rescue medication, pain intensity visual analogue scale, GPC, sleep quality, PSFS, RMDQ

Week 4

 

Day 15 to 28

Daily pain rating scale and daily medication intake if not recovered prior

Day 28

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.

Week 12

 

Day 29 to 84

Daily pain rating scale until recovery or day 84 if not recovered prior

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.