150 Chapter 7 METHODS Study design This study is a secondary cohort analysis using data from the e-Exercise LBP trial (19). The e-Exercise LBP trial was a multicenter cluster randomized controlled trial investigating the effectiveness of a stratified blended physiotherapy intervention in patients with LBP (20). Patients with LBP were recruited from 58 primary care physiotherapy practices in the Netherlands from January to June 2018. Patients received treatment from participating physiotherapists, and to avoid contamination between the intervention group and usual care group, physiotherapy practices were cluster-randomized to either the intervention group or usual care group. In the intervention group, physical therapy consisted of faceto-face physiotherapy treatment combined with support from an eHealth application on their smartphone (e-Exercise LBP) (20,21). Patients in the usual care group received care based on the guidelines for LBP from The Royal Dutch Society for Physiotherapy (22). The Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands, approved the study (ISRCTN 94074203). Participants Patients were eligible for participation if they (1) requested physiotherapy treatment for LBP (pain in the lumbosacral region sometimes associated with radiating pain to the buttock or leg) (22,23), (2) were aged 18 years or older, (3) had a smartphone or tablet with internet access, and (4) had B1-level proficiency in the Dutch language(24). Patients were excluded if a specific cause of LBP was determined through medical imaging, if they were diagnosed by a medical doctor (including pelvic girdle pain caused by current pregnancy), or if they suffered from serious comorbidities. When inclusion for the trial ended, a total of 208 patients participated in the study. Outcomes The outcomes measured were physical functioning, pain intensity, and recovery from LBP. The Oswestry Disability Index (ODI) version 2.1a (25,26) was used to measure physical functioning. A higher ODI score (range 0-100) indicates increased physical disability. The ODI is included in the “Core Outcome Set” for research involving patients with nonspecific LBP (27). The ODI change score was calculated by subtracting the ODI baseline score from the ODI score after three months. Pain intensity was measured using the Numeric Pain Rating Scale (NPRS) and was reported by the patient as an average score over the last seven days (26,28). If a patient experienced pain for fewer than seven days, the average pain intensity since the onset of pain was used instead. Pain scores on the NPRS range from 0 (no pain) to 10 (worst pain imaginable). The NPRS change score was calculated by subtracting the NPRS score at baseline from the NPRS score after three
RkJQdWJsaXNoZXIy MTk4NDMw