75 Effectiveness and cost-effectiveness of e-Exercise low back pain - study protocol Primary outcome measure The primary outcome measure is physical functioning and is derived from the internationally accepted “Core Outcome Set” (COS) for research into patients with nonspecific LBP. The other recommended outcomes are included as secondary parameters, i.e., pain intensity, health-related quality of life, psychological functioning and pain interference (43–45) (Table 2). All selected measurement instruments in the current study are determined to be valid and reliable in previous research. Physical functioning due to pain in LBP patients is assessed by the Oswestry Disability Index (ODI), version 2.1a (44–46). Secondary outcome measures Pain intensity is measured with an 11-point Numeric Rating Scale (NRS) for the average LBP intensity in the last week (44,45,47). Physical activity is objectively measured using a 3-axial accelerometer, the Activ8 (ACTIV8, Valkenswaard, The Netherlands) (48). The Activ8 is a valid instrument to detect sedentary behaviour (combination of lying and sitting), standing, walking, running, and cycling. Additionally, MET-values are given. The Activ8 measures with 12.5 Hz, an epoch of 1 s a sample interval of 5 s. Every 5 min a summary is stored of the different postures and MET-values (49). In addition, participants are requested to fill out a short activity diary about unusual activities and reasons for device removal. Patient self-reported adherence to prescribed home exercises is measured by the Exercise Adherence Rating Scale (EARS). Besides that, the EARS measures the exercise prescription and the reasons for (non-)adherence (50). Physiotherapist based assessment of adherence to prescribed home exercises is measured by the Exercise Adherence Scale (EXAS). The EXAS is an interview-based questionnaire which is used by the physiotherapist during face-to-face care to determine both the qualitative performance of the recommended home exercises and the agreement between recommended home exercises and patient reported adherence (51). Adherence to the smartphone application is measured in the experimental group only by means of quantitative data about usage (e.g., completed modules). The data is automatically stored on the backend of the smartphone application. Fear avoidance beliefs about physical activity and work is measured using the Fear- Avoidance Beliefs Questionnaire (FABQ). The FABQ assesses the fear of movement/(re) injury and consists of items related to physical activity and work (52). 4
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