Pain Education and Patient-led Goal Setting in Adults With Chronic Low Back Pain: a Randomised Controlled Trial

Pain intensity

Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale

Time frame: Weeks 8 and 52 post-randomisation

Disability

Self-reported disability assessed using the Roland Morris Disability Questionnaire (RMDQ); scale range 0-24; lower scores indicate lower disability

Time frame: Weeks 8 and 52 post-randomisation

Pain self-efficacy

Pain self-efficacy assessed using the Pain Self-Efficacy Questionnaire (PSEQ); scale range 0-60; higher scores indicate greater pain self-efficacy

Time frame: Weeks 8, 26 and 52 post-randomisation

Back beliefs

Back beliefs assessed using the Back Beliefs Questionnaire (BBQ); scale range 9-45, lower scores indicate more pessimistic beliefs about the consequences of low back pain

Time frame: Weeks 8, 26 and 52 post-randomisation

Kinesiophobia

Fear of movement (re)injury assessed by the short-form of the Tampa Scale of Kinesiophobia; scale range 4-16 (higher scores indicate greater kinesiophobia)

Time frame: Weeks 8, 26 and 52 post-randomisation

EuroQol 5-Dimension 5-Level (EQ-5D-5L)

Health-Related Quality of Life assessed using the EQ-5D-5L dimensions scale range, 1-5; higher scores indicate better quality of life) and health thermometer (range, 0-100; higher scores indicate better quality of life).

Time frame: Weeks 8, 26 and 52 post-randomisation

Daily step count

Average daily step count over the past 7 days assessed using accelerometry.

Time frame: Week 8 post-randomisation

Light intensity physical activity

Light intensity physical activity (min/day) over the past 7 days assessed using accelerometry

Time frame: Week 8 post-randomisation

Moderate-vigorous intensity physical activity

Moderate-vigorous intensity physical activity (min/day) over the past 7 days assessed using accelerometry

Time frame: Week 8 post-randomisation

Sedentary time

Sedentary time (min/day) over the past 7 days assessed using accelerometry

Time frame: Week 8 post-randomisation

Subjective physical activity levels

Self-reported physical activity over the previous 7 days assessed using the short-form of the International Physical Activity Questionnaire (IPAQ)

Time frame: Weeks 8, 26 and 52 post-randomisation

Lifestyle risk factors

Diet (do you eat less than two serves of fruit per day? (yes/no); do you eat less than fives serves of vegetables per day? (yes/no)). Alcohol intake (On average, how much alcohol do you drink each week? (I rarely/never drink alcohol; Less than 14 standard drinks; Between 14 and 21 standard drinks; More than 21 standard drinks)

Time frame: Weeks 8, 26 and 52 post-randomisation

Blood pressure

Blood pressure at rest assessed via an automated sphygmomanometer

Time frame: Week 8 post-randomisation

Adverse events

Adverse events assessed via self-report

Time frame: From randomisation to Week 8 post-randomisation

Adherence to treatment

Adherence to treatment assessed via session attendance and self-report (diary)

Time frame: From randomisation to Week 8 post-randomisation

Total healthcare costs

Total health-care costs will be estimated as the trial intervention costs and outside trial health-care resource use attributable to chronic low back pain from the Medicare Benefits Scheme and Pharmaceutical Benefits Scheme. Quality-adjusted life-years (QALYs) from the EQ-5D-5L using the Australian utility weights will also be used in the trial-based cost-utility analysis.

Time frame: Weeks 8, 26 and 52 post-randomisation

Goal attainment (goal setting arm only)

Goal attainment assessed using the goal attainment scale. Each goal is rated on a 5-point scale: +2 = much more than expected, +1 = somewhat more than expected, 0 = Patient achieves the expected level, -1 = somewhat less than expected, -2 = much less than expected.

Time frame: Weeks 8, 26 and 52 post-randomisation