Table 1

Trial data collected and their purpose

ConstructMeasureTime points (weeks)Purpose
AgeDate of birth0Describe population
SexMale/female0Describe population
Duration of episodeWeeks0Describe population
Duration since care-seekingWeeks0Describe population
Previous lifetime episodesNumber0Describe population
Heightcm0Describe population
Weightkg0Describe population
EducationCategorical0Describe population
Current roleCategorical0Describe population
EmployedYes/no0Describe population and analysis of economic efficiency
OccupationOpen text0Describe population and analysis of economic efficiency
Hours workingHours0Describe population and analysis of economic efficiency
Days workingDays0Describe population and analysis of economic efficiency
Sick leave last 3/12Yes/no0, 12, 26, 40 and 52Describe population and analysis of economic efficiency
Days of sick leave 3/12Days0, 12, 26, 40 and 52Describe population and analysis of economic efficiency
Pain-related physical activity limitationRoland Morris Disability Questionnaire46 0, 3, 6, 12, 26, 40 and 52Describe population, primary outcome, analysis of economic efficiency
Functional limitationPatient-Specific Functional Scale47 0, 3, 6, 12, 26, 40 and 52Secondary outcome
Pain intensityNumeric Pain Rating Scales31 0, 3, 6, 12, 26, 40 and 52Describe population, secondary outcome
Fear avoidance beliefsFear Avoidance Beliefs Questionnaire (physical activity sub-scale)35 0, 12, 26, 40 and 52Describe population, secondary outcome, mediator
Analgaesic useParticipant self-report text box0Describe population, secondary outcome (when matched to 12 month Pharmaceutical Benefits Scheme data)
CatastrophisingPain Catastrophizing Scale33 0, 3, 6, 12, 26, 40 and 52Describe population, secondary outcome, mediator and moderator
Pain self-efficacyPain Self-efficacy Questionnaire34 0, 3, 6, 13, 26, 40 and 52Describe population, secondary outcome, mediator and moderator
Quality-adjusted life yearsEuroQOL EQ-5D-5L30 0, 12, 26, 40 and 52Analysis of economic efficiency outcome
Treatment expectationsA tailored question, based on Rofail et al 48 0 (post-randomisation)Clinical effectiveness baseline covariate
Confidence in interventionA tailored question, based on Rofail et al 48 3 (CFT groups only)Mediator
Cognitive flexibilityCognitive Flexibility Inventory49 0Moderator
Therapeutic allianceWorking Alliance/ Theory of Change Inventory44 3 (CFT groups only)Moderator
Risk stratificationKeele STarT MSK Tool43 0Moderator
Patient-perceived global improvementTailored question, based on Kamper et al recommendations36 12, 26, 40 and 52Secondary outcome
Satisfaction with care and treatmentTailored question, based on Client Satisfaction Questionnaire50 12Secondary outcome
Productivity costsiMTA Productivity Cost Questionnaire38 12, 26, 40 and 52Analysis of economic efficiency
Direct health costs attributable to consumption of healthcare resourcesExtracts from Medicare and Pharmaceutical Benefits Scheme databases and direct patient report12, 26, 40 and 52Analysis of economic efficiency
Functional movementWearable wireless sensors (DorsaVi P/L)Every consultation (CFT groups only)Mediator
Adverse eventsTailored question, based on recommendations of the Council for International Organisations of Medical Sciences Working Group VI51 3, 6, 12, 26, 40, 52 and every consultationMonitoring adverse events

  • CFT, cognitive functional therapy; EQ-5D-5L, 5-level EuroQol Five Dimension.