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Randomized controlled trial of a 12-week digital care program in improving low back pain
According to the World Health Organization, low back pain (LBP) is the leading cause of disability worldwide with a global prevalence of 7.2%, affecting 4 in 5 individuals in their lifetime., Clinical diagnosis of LBP is difficult due to its multifactorial etiology and in turn, 90% of cases are designated as non-specific with no clear underlying cause., Given the uncertainties in diagnoses, localized LBP is treated with a broad variety of interventions including activity modification, physical therapy, pain medication, and spine injections. If symptoms do not improve, surgical intervention may be recommended. In the US, the economic costs of LBP are the highest in the world exceeding $100B per year  and this is in part due to the high rates of surgical intervention. Health systems are not equipped to manage this growing population affected by LBP.
Patients pursuing non-invasive treatments have better outcomes for reducing disability and returning to work compared to those pursuing surgical intervention. In an evidence-based guideline, the American College of Physicians recommends to first pursue non-pharmacological conservative treatments for LBP because they are deemed less harmful. While exercise, rehabilitation, and cognitive behavioral therapy are among the most effective non-pharmacological conservative care treatments for ameliorating LBP symptoms, implementations of such care from a traditional clinical model has, so far, revealed inconsistent results., This is likely due to the high degree of patient engagement, commitment, and self-management needed to adhere and complete these time-intensive at-home treatment plans. The amount of patient engagement in a treatment plan is shown to directly relate to health outcomes, and is often an overlooked component in otherwise promising interventions.
Digital health technology can provide care for a large population and improve outcomes for non-invasive treatments by allowing providers to monitor adherence and activate patients to engage in their recovery. A digital therapy approach can integrate multiple conservative care channels while also tracking outcomes and providing biofeedback. The utilization of self-regulatory tools such as biofeedback as an engagement tool in non-specific LBP rehabilitation has been shown to promote greater than 80% adherence. Biofeedback enables patients to better learn how to voluntarily control and track therapeutic exercise by converting physical movement into meaningful visual and auditory cues. Biofeedback is believed to help patients gain awareness of their movement physiology and learn to self‐regulate and even challenge themselves to make progress in response to the real-time feedback.
Surprisingly, results from prior randomized controlled trials of digital intervention on managing LBP with conservative care are largely unconvincing with only one prior study demonstrating a positive effect from a 3-week cognitive behavioral therapy digital intervention. Beyond the variability in theoretical underpinnings behind prior digital intervention studies, other issues may include the passive dissemination of content to patients and not assessing patient engagement. A digital care program (DCP) similar to the program tested here has recently been shown to be effective in alleviating knee pain outcomes and intent for surgery., The conservative care components of this unique DCP, including aerobic exercise, sensor-guided physical therapy-like exercises, patient education, and cognitive behavioral therapy, are known to be effective in treating LBP.,,,,
In addition, the inclusion of personal health coaching, education, and group support are aimed at enhancing patient engagement in self-management of their symptoms.
In this study we assessed the efficacy of a 12-week DCP for LBP in a two-armed, pre-registered, randomized, controlled trial (RCT). Participants randomized into the treatment group received the 12-week DCP, consisting of sensor-guided exercise therapy, education articles, cognitive behavioral therapy, team discussions, activity tracking, symptom tracking, and 1-on-1 coaching, all from their home through a dedicated app on a complementary tablet computer. Participants randomized into the control group received three digital education articles only, and all participants maintained access to treatment-as-usual. that can include physician visits, pain medication, diagnostic imaging, and potential recommendations for later injections and/or surgery. Based on evidence of the potential for non-invasive therapies for treating LBP, we hypothesized that strong engagement with these multi-model conservative care approaches would improve pain and disability scores (primary outcomes), and subject understanding of their condition and their interest in surgery (secondary outcomes), compared to the control group. These outcomes as well as the eligibility criteria were registered prior to the initiation of the study (ISRCTN #42338218).
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Randomized Controlled Trial
Methods and Results
This study was a two-armed, randomized, controlled, unblinded trial of participants with chronic non-specific LBP. Employees and their dependents at participating employers, across 12 locations in the US, were invited to complete an online application. Employees were highly diverse, and included both office and service based roles such as data analysts, drivers, catering staff, and outdoor instructors. Participants were recruited through emails, direct mail, and posters between January and March, 2017. The trial was approved by the Western Institutional Review Board and we have complied with all ethical regulations. Participants provided informed consent and completed the intervention at home. The trial was preregistered at International Standard Randomized Controlled Trial Number (ISRCTN) 42338218. We followed CONSORT guidelines for reporting this trial.
We assessed the eligibility of all applicants that completed the baseline questionnaire for LBP through a web-based questionnaire. Participants provided informed consent as part of this questionnaire by ticking a checkbox after reading the digital information sheet. The inclusion criteria were: (1) age over 18 years, (2) non-specific LBP for at least 6 weeks in the past 12 months, (3) participating in the collaborating employers’ health plans, and (4) provision of informed consent. The exclusion criteria were (1) surgery on the back less than 3 months ago, (2) injury to the back less than 3 months ago, (3) did not indicate ‘lower back’ when asked about pain location. As there were a limited number of places available on the program, eligible applicants were prioritized for enrollment, with those exhibiting greater pain, disability, and surgery intent prioritized over those showing less. Applicants not selected for the study were placed on a waitlist for future deployments at the same site outside of the scope of the trial. Participants were not paid for their time, other than an incentive offered to complete the outcome questionnaire for those participants that did not complete it within 4 days of first invitation. No harm was observed or reported in either arm of the experiment.
Applicants were randomized into the trial twice weekly during the signup period by randomizing batches of participants into treatment and control using a 60:40 treatment-to-control ratio (n = 128) or using an 80:20 ratio (n = 49). The 80:20 ratio was used for a restrictive period of time due to administrative error. The effective allocation ratio was therefore 64:36 treatment-to-control. When a batch of applicants was randomized, an algorithm with random seed shuffled the batch and selected the first 60% to enter the treatment, and the remaining 40% to enter control. The person reviewing the applicants had no way of knowing whether any given applicant would enter treatment or control (concealed allocation). After randomization, participants in the treatment group received an email inviting them to complete their profile and received the kit to participate in the DCP, whereas those in the control group received an email with three education articles to help them care for their back. Due to the nature of the study, neither the study staff nor the participants were blinded to group allocation.
The treatment group received a 12-week DCP for LBP developed by physical therapists, medical doctors, engineers, and subject-matter experts at a digital health company. Participants received a tablet computer with the DCP app installed, and two bluetooth wearable motion-sensors with straps to be placed along the lower back and torso during the in-app exercise therapy. Participants were assigned a personal coach that provided unlimited support and accountability throughout the program and were placed in a team to provide peer support through a discussion feed within the app. All app participation was completed remotely, at times and places chosen by the participant. Each week, participants in the DCP were instructed to complete 3 sessions of sensor-guided physical exercise, read 1 to 2 education articles, log their symptoms at least twice, perform cognitive behavioral therapy on a subset of weeks, and track a recommended 3 aerobic activities per week. Each participant also maintained access to treatment as usual.
The control group received three digital education articles from the DCP. These articles discussed the importance of self-care, how to deal with setbacks in LBP, and how to manage communication and relationships when living with chronic LBP. The control group maintained access to treatment-as-usual and were informed that they would be reconsidered for the program when enrollment reopened after the 12-week study.
The 12-week program received extensive testing over a 2-year period prior to starting the trial. All participants received the same version of the program, and there were no major app updates during the course of the trial.
Participants completed the Modified Von Korff (MvK) scales at screening and at week 11 (control group), or screening, week 4, week 8, and week 11 (treatment group). The MvK yields a pain and a disability metric, from 0 (min) to 100 (max). The third primary outcome was the Oswestry Disability Index (ODI) which falls between 0 (none) to 100.
The ODI was collected at baseline and week 11 for both treatment and control groups. To conclude a positive effect of treatment we required a significant effect on all three primary outcomes, though we note this was not specified in the preregistration.