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Table 3 Primary, secondary and exploratory outcome analysis at all follow-up time points, week 6, 12, 26 and 52

From: Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial

Outcome

Time point

Intervention (n = 172)

Control (n = 172)

Intervention – controla

Disability RMDQ score (0–24)

 Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Pain intensity score (0–10)

 Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Weight (subjective, kg)

 Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Weight (objective, kg)

 Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

BMI (using subjective height and weight, kg/m2)

 Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

 Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Quality of life

Physical component score

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Mental component score

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Smoker (y)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

Physical activity

Minutes/week of at least moderate activity

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

MET-minutes/week of low physical activity levels

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

MET-minutes/week of moderate physical activity levels

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

MET-minutes/week of high physical activity levels

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Nutrition diet quality score (5–15)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Poor sleep quality (y)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

Pain self-efficacy (0–12)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Psychological distress (6–30)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Usual alcohol consumption (0–8)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Medication use for back pain in previous 6 weeks (y)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

Use of other health care services for back pain in previous 6 weeks (y)

  Baseline

n/N (%)

n/N (%)

OR (95% CI)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

Carer, community or homecare services use in previous 6 weeks (y)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

Absence from work in last 6 weeks due to back pain (days)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Days at work ill with back pain in last 6 weeks (number)

  Week 6

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 12

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 26

Mean (SD)

Mean (SD)

Mean diff (95% CI)

  Week 52

Mean (SD)

Mean (SD)

Mean diff (95% CI)

Adverse events (y)

  Week 6

n/N (%)

n/N (%)

OR (95% CI)

  Week 12

n/N (%)

n/N (%)

OR (95% CI)

  Week 26

n/N (%)

n/N (%)

OR (95% CI)

  Week 52

n/N (%)

n/N (%)

OR (95% CI)

  1. aAdjusted as per analysis approach. RMDQ Roland Morris Disability Questionnare, BMI body mass index, y yes, Mean diff mean difference between groups, CI Confidence interval, SD standard deviation, OR odds ratio