CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Background: Nonspecific low back pain (NLBP) is the diagnosis for individuals feeling back pain that has no underlying medical cause (e.g., tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and the American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than four weeks. This approach, however, is impractical for many physicians to implement during office visits, and relatively few providers offer NLBP treatment that follows ACP guidelines. Objectives: This study evaluated the efficacy of an on-line intervention called FitBack, which used a responsive design architecture on computers and mobile devices to help users develop self-tailored strategies designed to treat NLBP occurrences and adopt behaviors to decrease future pain occurrences. Methods: A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at two months (T2), and at four months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received a list of Internet resources for NLBP, and control. The FitBack and alternative care groups received weekly email reminder prompts for 8 weeks plus emails to do assessments, while the usual care group was only contacted to do assessments. 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Background: Nonspecific low back pain (NLBP) is the diagnosis for individuals feeling back pain that has no underlying medical cause (e.g., tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and the American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than four weeks. This approach, however, is impractical for many physicians to implement during office visits, and relatively few providers offer NLBP treatment that follows ACP guidelines. Objectives: This study evaluated the efficacy of an on-line intervention called FitBack, which used a responsive design architecture on computers and mobile devices to help users develop self-tailored strategies designed to treat NLBP occurrences and adopt behaviors to decrease future pain occurrences. Methods: A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at two months (T2), and at four months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received a list of Internet resources for NLBP, and control. The FitBack and alternative care groups received weekly email reminder prompts for 8 weeks plus emails to do assessments, while the usual care group was only contacted to do assessments. 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Background: Nonspecific low back pain (NLBP) is the diagnosis for individuals feeling back pain that has no underlying medical cause (e.g., tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and the American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than four weeks. This approach, however, is impractical for many physicians to implement during office visits, and relatively few providers offer NLBP treatment that follows ACP guidelines. Objectives: This study evaluated the efficacy of an on-line intervention called FitBack, which used a responsive design architecture on computers and mobile devices to help users develop self-tailored strategies designed to treat NLBP occurrences and adopt behaviors to decrease future pain occurrences. Methods: A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at two months (T2), and at four months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received a list of Internet resources for NLBP, and control. The FitBack and alternative care groups received weekly email reminder prompts for 8 weeks plus emails to do assessments, while the usual care group was only contacted to do assessments. 1b-iv) RESULTS section in abstract must contain use data Results: In all comparisons, the FitBack group showed favorable mean outcome scores relative to either the alternative care or control groups. Seven of the twelve omnibus tests at T2 and eight of the twelve omnibus tests at T3 were statistically significant and warranted follow-up comparisons. All FitBack vs. usual care control follow-up comparisons were statistically significant at T2 and at T3. For FitBack vs. alternative care group, three of seven T2 comparisons were statistically significant with small effect sizes, but seven of the eight comparisons at T3 were statistically significant with small effects sizes. Study participants reporting current back pain at T3 were approximately 1.6 times more likely to be in the alternative care group and 1.7 times more likely to be in the control group than in the FitBack group 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials