Table 1 Trial Measures
Outcome | Domain | Measures | Time point (weeks) |
|---|---|---|---|
Primary | Pain intensity | Pain intensity over the previous week as measured by the 0–10 Numerical Rating Scale (NRS) [26] | 0, 2, 6, 10, 14, 18, 22, 26 |
Secondary | Disability | Roland Morris Disability Questionnaire (RMDQ) [28] | 0, 6, 26 |
Self-reported weight | Self-reported weight (kg) | 0, 6, 26 | |
Objective weight | Measured to the nearest 0.1 kg [29] | 0a, 26 | |
BMI | Calculated as weight/height squared (kg/m2) | 0a, 26 | |
Waist circumference | Measured to the nearest 0.1 cm [29] | 26 | |
Quality of life | Short Form 12 version 2 (SF12.v2) [30] | 0, 6, 26 | |
Perceived change in condition | Global Perceived Effect Scale [43] | 6, 26 | |
Psychological distress | Depression, Anxiety and Stress Scale-21 (DASS-21) [31] | 0, 26 | |
Sleep quality | Item 6 of the Pittsburgh sleep quality index [32] | 0, 6, 26 | |
Health behaviours | Physical Activity measured using the Active Australia Survey [33] | 0, 6, 26 | |
Dietary intake measured using a short food frequency questionnaire [34] | 0, 6, 26 | ||
Alcohol Consumption measured using the alcohol use disorders identification test (AUDIT) [35] | 0, 6, 26 | ||
Self-reported smoking status [36] | 0, 6, 26 | ||
Health care utilisation | Medication use for low back pain | 0, 6, 26 | |
Visits for low back pain – type and number of sessions | 0, 6, 26 | ||
Attended orthopaedic consultation, received surgery | 26 | ||
Pain attitudes | Survey of Pain Attitudes (SOPA) [38] | 0, 6, 26 | |
Fear Avoidance | Fear Avoidance Beliefs Questionnaire (FABQ) [39] | 0, 26 | |
Economic | Quality of life (SF12.v2) | 0, 6, 26 | |
Health care utilisation (including estimated out of pocket cost) | |||
Absenteeism (days off normal work due to lower back pain in the past 6 weeks) |