This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP.
The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP.
This is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months.
The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.
This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.
ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288
DERR1-10.2196/14720
Low back pain (LBP) is a leading contributor to years lived with disability [
Clinical guidelines recommend education, exercise therapy, multidisciplinary treatments, and combined physical and psychological interventions for the management of LBP [
Digital solutions such as mobile apps can be used as platforms for supporting self-management [
In the selfBACK project, we have developed an evidence-based and data-driven decision support system (DSS) delivered via a smartphone app to facilitate, improve, and reinforce self-management of nonspecific LBP. The design and implementation of the selfBACK DSS have been described elsewhere [
Inclusion and exclusion criteria are outlined in
Inclusion criteria:
Danish or Norwegian adults (aged 18 years and older)
History of low back pain of any duration in patients having sought care for their low back pain within the preceding 8 weeks from primary practice (general practice, physiotherapy, or chiropractic serving as first point of contact) or a specialized outpatient hospital facility (Denmark)
Must score mild to severe pain-related disability rated as 6 or above on the Roland-Morris Disability Questionnaire
Must own and regularly use a smartphone with internet access
Must have a working email address and access to a computer with internet access
Exclusion criteria:
Unable to speak, read, or understand the national language (Danish or Norwegian)
Cognitive impairments or learning disabilities limiting participation
Mental or physical illnesses or conditions limiting participation as assessed by the referring health care professional or the participant
Inability to take part in exercise or physical activity
Fibromyalgia (diagnosed by a health care professional)
Pregnancy
Previous back surgery
Ongoing participation in other research trials for low back pain management
Recruitment is performed in Trondheim, Norway, and Odense, Denmark. The recruitment flow is described in
Interested patients are screened via telephone by a member of the research team. If eligible and willing to participate, participants give their verbal consent to participate and are invited to complete the baseline questionnaire. Thereafter participants give their written consent to participate and are randomized to one of two groups.
Participant flow through the selfBACK trial. The dashed lines indicate who the participant interacts with during the screening process and randomization. GP: general practitioner; PT: physiotherapist; C: chiropractor; HCP: health care professional; LBP: low back pain.
Participants are randomized to either (1) selfBACK DSS in addition to usual care or (2) usual care only. Randomization is performed as a block randomization with permuted blocks of random size and stratified by country and care provider (ie, general practitioner, physiotherapist, chiropractor, or Spine Centre). The allocation ratio between groups is 1:1. Randomization is performed in a Web-based trial management system (Web Case Report Form [WebCRF]) developed and administered by the Unit of Applied Clinical Research, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway. The WebCRF system holds a minimal dataset on all screened participants (variables include trial indentification number, participant initials, country, type of HCP recruiting participant, age, and gender). The study is single-blinded; participants are not blinded to group allocation. Analysis and interpretation of the study results will be performed by researchers blinded to group allocation.
The trial and intervention are described following the Standard Protocol Items: Recommendations for Interventional Trials [
Participants receive usual care as deemed appropriate by their HCP. This includes any diagnostic procedure, treatment, or referral the HCP finds relevant considering the case history, clinical findings, and pragmatic, daily clinical practices. Participants can seek care, treatment, or help elsewhere as they find relevant. After the completion of the trial at 9 months, participants in this group are offered a wearable device like the one given to the selfBACK group.
The selfBACK app presents participants with weekly tailored self-management plans consisting of recommendations on number of steps per day, educational material, and a program for strength and flexibility exercises. The process of tailoring the weekly self-management plan has been described elsewhere [
The content for the app was developed using an intervention mapping process [
The bank of physical exercises holds 56 strength and flexibility exercises organized in 5 targets and 14 pain-relief exercises (
Physical activity is tracked using a wearable device (Mi Band 3, Xiaomi). The wristband shows the achieved step count per day. Educational messages and notifications aimed to motivate more physical activity are pushed to the participant through the app based on the step count data.
Overview of the content of self-management plans.
Data available | Physical activity | Physical exercise | Education |
Information from preceding week | Achievement of preceding week’s step goal | Completion of exercise sessions | Completion of educational messages and quizzes |
Content available | Physical activity registration: Step count registration by wristband Individualized feedback for daily, weekly, and monthly step count Advice to stay active Motivational messages to increase physical activity |
Exercise targets: Abdominals Back extensors Core stability Gluteal and hip muscles Flexibility Pain relief |
Message themes: Information about LBPa Understanding mind-body connection Self-management for LBP Thoughts, behavior, attitude, and feelings Fitting in self-management in a busy life First aid when your back hurts LBP and comorbidities Goal-setting and action planning Pacing and progression Problem-solving Relaxation Sleep and LBP Social support Overcoming barriers for self-management Sleep reminder and sleep hygiene Mindfulness Goal-setting |
aLBP: low back pain.
The primary outcome is pain-related disability at 3-month follow-up assessed using the RMDQ [
Descriptive variables include age, gender, height, weight, and report of any comorbidities (comorbidities were registered using an existing questionnaire (HUNT3) from the Norwegian HUNT study [
A range of secondary and exploratory outcomes is included in the trial, and participants randomized to use the selfBACK app in addition to usual care are asked a set of tailoring questions weekly to individualize their self-management plan (
Overview of the information collected at baseline, during the weekly tailoring sessions, and at follow-ups at 6 weeks and 3, 6, and 9 months.
Characteristics | Baseline | Weekly tailoring | Follow-ups | |
|
|
|
|
|
|
Participant characteristics | x |
|
|
|
Sociodemographics | x |
|
|
|
|
|
|
|
|
Roland-Morris Disability Questionnaire [ |
x |
|
x |
|
|
|
|
|
|
Average pain intensity past week | x | x | x |
|
Worst pain intensity past week | x |
|
x |
|
Duration of current episode with low back pain | x |
|
x |
|
Pain medication frequency past week | x |
|
x |
|
Fear-Avoidance Belief Questionnaire [ |
x | xa | x |
|
Pain Self-Efficacy Questionnaire [ |
x | xb | x |
|
Activity limitation, work and leisure | x |
|
x |
|
Work ability index (single-item) [ |
x | x | x |
|
Saltin-Grimby Physical Activity Level [ |
x |
|
x |
|
Patient Specific Function Scale [ |
x |
|
x |
|
Sleep problems [ |
x | xb | x |
|
Perceived Stress Scale [ |
x | xb | x |
|
Quality of life: EuroQoL 5-Dimension [ |
x |
|
x |
|
Brief Illness Perception Questionnaire [ |
x |
|
x |
|
Patient Health Questionnaire–8 [ |
x | xb | x |
|
Global Perceived Effect |
|
|
x |
|
Patient Acceptable Symptom State |
|
|
x |
|
Perceived barriers |
|
x |
|
|
Pain-related function |
|
xc |
|
aFear-avoidance assessed with single-item Tampa scale [
bReduced number of items or single items.
cFunction assessed with single items from Chronic Pain Grade Scale [
Outcome measures are collected at baseline, 6 weeks and 3, 6, and 9 months. Data collection is Web-based, and all data are entered directly into the selfBACK database by the participants. To maximize response rate, reminder emails are sent after 3 days and again after 6 days if no response to the first email. If still no answer, a researcher will contact the participant and ask if they are willing to answer the RMDQ questionnaire over the phone at follow-ups.
All outcome and other data are stored on secure servers at NTNU, the servers are firewall protected, and back-up is performed daily. Data storage is consistent with national (Denmark and Norway) and European regulations on data protection. Also, all data transferring processes are protected using https and Secure Sockets Layer as well as sending the data in encrypted format.
The sample size calculations have been performed in two ways. First, we performed a calculation assuming only one follow-up measure and a standard deviation of the RMDQ score of 6 points. The expected standard deviation was informed by previous high-quality studies in Denmark and United Kingdom investigating similar LBP populations [
Second, we performed a simulation using 1000 repetitions of a mixed-model regression for repeated measures assuming (1) 3 data points per participant (ie, baseline, 6 weeks, and 3 months), (2) a 2-point difference between groups on RMDQ at 3 months, (3) a standard deviation of 6 points, and (4) a correlation between repeated measures of 0.4. The latter was based on information from previous trials with repeated measures for the RMDQ in similar LBP populations [
The primary analysis will estimate mean group difference with 95% confidence interval of the RMDQ score over the first 3 months. Analyses will be conducted according to the intention-to-treat principle using a linear mixed model for repeated measures. This model includes all available data for all participants at each time point (ie, baseline, 6 weeks, and 3 months). In the regression model, individual participants will be specified as a random effect, accounting for the within-subject covariance structure. The effect of group and time will be specified as fixed effects using a joint variable of intervention and time. The analysis will investigate the effect of the intervention as constant over time, as well as an interaction between time and group allocation. Here, baseline levels are pooled over the two study groups assuming that any baseline differences are due to chance [
To increase transparency, a statistical analysis plan will be agreed upon and made publicly available before ending the collection of the primary outcome. To reduce the risk of biased interpretation of results, the following procedure will be undertaken: two interpretations will be drafted based on a review of the primary outcome data with groups arbitrarily labeled A and B [
A process evaluation exploring how participants use the intervention in daily life will be conducted as an integrated part of the RCT. For this we will use a mixed-methods process evaluation: gathering quantitative measures by questionnaires for participants including the Virtual Care Climate Questionnaire [
The trial was approved by the national ethical committees in Denmark (S-20182000-24) and Norway (2017/923-6). Correspondingly, national review boards or data protection agencies have approved the trial. In Denmark, approval was granted from the Danish Data Protection Agency through application to the University of Southern Denmark’s legal office (201-57-0008) and in Norway from the National Data Protection Authority or the Centre for Research Data through the ethics approval. The trial is registered with ClinicalTrials.gov [NCT03798288].
The trial results will be reported in accordance with the CONSORT 2010 reporting guideline and the 2013 CONSORT-EHEALTH checklist amendment for reporting Web-based and mobile-based RCTs [
No serious adverse events are expected for this trial. Should a participant contact the research team concerning any worsening of symptoms, the participant will be advised to seek care from their HCP as they normally would. All inquiries regarding potential adverse events will be recorded and discussed in an internal audit and reported with the study results. In addition, the selfBACK DSS is designed to react to increased pain or deterioration in symptoms, and it will adjust the self-management plans based on this information. In addition, participants are informed in the written information and during the screening call and inclusion process that this intervention is an add-on to usual care and should not replace contact with their HCP and that they should always follow the advice of the consulting HCP. Also, the app contains a Caution section describing worsening in symptoms that should be acted upon and advising participants to seek care from their consulting HCP if they experience any such symptoms.
Recruitment to the trial started in early 2019 and is expected to run until the end of 2019. Data collection is expected to be complete by September 2020, and dissemination of trial results is planned thereafter. The results on the primary outcome is expected to be ready during fall 2020.
This protocol describes the design and methods of the selfBACK trial assessing the effectiveness of the selfBACK app in addition to usual care in helping people with nonspecific LBP manage their condition. Digital solutions have been described as promising platforms for supporting people in managing chronic conditions [
The content of the selfBACK intervention was developed using an intervention mapping process and is therefore theoretically underpinned and evidence-based [
It is important to recognize that the content of usual care will differ for participants both within and across study centers (countries) of this trial. This is a common problem in trials where usual care is the comparator. However, it is also a reflection of how LBP is managed in a real-life setting. Thus, the results of the trial will have a high degree of external validity. In addition, the process evaluation for the trial will address perceptions of usual care through interviews with participants from the usual care group as well as with participants using the selfBACK app.
Similarly, the content of the suggested self-management plans will vary for participants using the selfBACK app. The app presents tailored self-management plans with three components: exercise, physical activity, and educational material. However, it is very likely that some components will appeal more to some participants than others. Therefore, should the RCT show the selfBACK app in addition to usual care to be more effective than usual care only, the trial design does not allow analyses of which components of the intervention may be causal of such an effect, although the process evaluation may provide some useful insights regarding such issues.
The outcomes from this trial will provide valuable new insights into the potential of mHealth solutions to support effective self-management in relation to LBP, while the parallel process evaluation will aid understanding of barriers and facilitators to uptake, use, and wider implementation of the intervention. The effectiveness of the app will be evaluated on the primary outcome; however, a range of secondary outcomes is included to elucidate the variation in and complexity of symptoms in people with LBP.
case-based reasoning
Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth
decision support system
University of Glasgow
health care professional
low back pain
National Research Centre for the Working Environment
Norwegian University of Science and Technology
randomized controlled trial
Robert Gordon University
Roland-Morris Disability Questionnaire
University of Southern Denmark
Web Case Report Form
The selfBACK project has received funding from the European Union Horizon 2020 research and innovation program under grant agreement number 689043. The funding body supervises the conduct of the overall project but is not involved in the planning, implementation, and interpretation of the RCT. NTNU is leading the development of the underlying structure for the database and DSS, Robert Gordon University (RGU) is leading the physical activity monitoring, and the private company Trade Expansion is leading the mobile app development. University of Southern Denmark (UoSD) is lead in the planning and conducting of the RCT. UoSD, National Research Centre for the Working Environment (NFA), NTNU, University of Glasgow (GLA), and RGU developed the content for the app. Participants will be recruited at NTNU and UoSD; NTNU is leading the overall project. Ownership of the data collected in the selfBACK trial is shared between the participating partners (NTNU, GLA, RGU, NFA, and UoSD). A data steering committee will be established that will be competent to decide over the use of the data. The steering committee will comprise one member from each participating partner. The selfBACK consortium supports the concept of data sharing, and inquiries from outside research partners to use the data are welcomed and will be discussed and decided upon by the steering committee.
LFS provided the first draft of the manuscript, and PJM and KS critically scrutinized the first draft and provided comments. TILN, MJS, and JH gave specific input to sample size calculation, and KB gave specific input to the description of the data storage and DSS function. MJS, MS, KW, CNR, BN, and FSM designed the process evaluation. All authors participated in the design and content of the RCT and all authors read, commented on, and approved the final manuscript prior to submission.
The overall aim of the selfBACK project is to develop a digital DSS and mobile app to support participants to self-manage their LBP. The results and experiences from the pilot and RCT will inform the further development of the selfBACK system, which may be introduced into a commercial market. If the selfBACK system is introduced into a commercial market, it will be done by a separate company that will have obtained a license to take the app to market. Any profit from such a transaction will be received by the participating universities and not by individual authors. In order to secure an unbiased interpretation and dissemination of the RCT, interpretation of the results will be performed blind to group allocation. Upon publication of study results, this commercial potential in the app development will be clearly stated, and the publication will undergo peer review to ensure methodological and scientific rigor. Additionally, the overall conduct of the trial is overseen by biannual review from the European Union, which is funding the project.