Effectiveness of the SelfBack-App in Preventing and Treating Low Back Pain Versus no Intervention: a Non-randomized Clinical Trial

Low back pain (LBP) is a frequent condition that can affect daily functioning, physicalactivity, and work participation. Healthcare professionals, including nurses, assistantnurses, and logistical staff, are considered a population at increased risk because theirprofessional activities often involve physical demands such as patient handling,repetitive movements, prolonged standing, and manual tasks.The present study evaluates the effectiveness of the SelfBack application, a digitaldecision‐support system designed to support the prevention and self‐management ofnon‐specific low back pain. The SelfBack system provides participants with individuallyadapted weekly recommendations through a smartphone application. These recommendationsconsist of exercise suggestions, activity goals, and educational information aimed atsupporting participants in managing their symptoms and maintaining physical activity.The study was initially designed as a single‐centre clinical trial. Following anamendment dated 17/07/2026, the study was expanded into a multicentre trial to include anadditional recruitment site. In addition to Universitair Ziekenhuis Brussel (UZ Brussel),Ziekenhuis Valida will participate in the recruitment of participants. This modificationwas introduced because recruitment was progressing more slowly than initially expected.Expanding recruitment to a second centre allows a larger number of eligible healthcareworkers to be approached and improves the feasibility of completing participant inclusionwithin the planned timeframe.The study compares two approaches: usual care combined with access to the SelfBackapplication and usual care without additional digital intervention. The aim is todetermine whether the addition of a digital self‐management support system can improveoutcomes related to low back pain compared with usual care alone.The SelfBack application is a digital decision‐support system that provides participantswith a personalized weekly self‐management plan. The recommendations are generated basedon information collected from the participant and are adapted according to changes insymptoms and activity levels throughout the intervention period.Participant information is obtained through an initial questionnaire, repeatedself‐reports within the application, and activity information collected through astep‐counting device. These data are used by the SelfBack system to providerecommendations that correspond with the participant's individual situation.Exercise adherence is monitored through the application, where participants indicatewhether suggested activities have been performed.The SelfBack application is used only for delivering the intervention content, includingeducational information, activity recommendations, and exercise guidance. Studyquestionnaires and Patient‐Reported Outcome Measures (PROMs) are collected separatelythrough REDCap.This study is designed as a multicentre randomized controlled clinical trial with twoparallel groups. Participants are recruited among healthcare workers employed in selecteddepartments of UZ Brussel and Ziekenhuis Valida.Allocation to the intervention or control condition is determined according to thedepartment in which participants work. This approach allows implementation within theclinical environment while avoiding practical difficulties associated with individualrandomization among colleagues working in the same unit.Participants allocated to the intervention group receive access to the SelfBackapplication in addition to usual care. Participants allocated to the control groupcontinue with usual care without access to the digital intervention during the studyperiod.The study follows a pragmatic design, meaning that participants continue to receive theusual healthcare support available in their normal setting. Additional treatments, suchas consultations with healthcare professionals, physiotherapy, or medication use, are notrestricted and may continue according to standard practice.The total duration of participation is twelve months. Follow‐up assessments are performedafter three, six, and twelve months to evaluate changes over time.Before any study‐related procedure takes place, participants receive information aboutthe study and are given sufficient opportunity to consider participation. Writteninformed consent is obtained before enrolment.The informed consent procedure has been adapted to allow electronic signing of theinformed consent form. Participants can complete the electronic informed consent processwhen they are logged into a hospital computer using their personal identification throughthe badge reader system. This modification was introduced to simplify the consentprocedure while maintaining secure identification of participants.Data collection within this study is performed digitally. All study‐relatedquestionnaires and Patient‐Reported Outcome Measures (PROMs) are collected through REDCap(Vanderbilt University, Nashville, USA), which is used as the Electronic Data Capture(EDC) system for the registration and management of study data.The SelfBack application remains the digital tool used for delivering the intervention,including educational information, exercise recommendations, and personalized activityplans. REDCap is used specifically for collecting and storing study questionnaires andclinical research data.Access rights are assigned according to the responsibilities of each study team memberand are controlled throughout the study period. Study data are entered within areasonable timeframe following completion of study assessments. Any modifications made toentered data are automatically documented through an audit trail, including informationregarding the date, time, and person responsible for the modification.All collected information is handled according to applicable data protectionrequirements.After enrolment and completion of the informed consent procedure, participants start thestudy according to their assigned study group.Participants allocated to the control group continue receiving usual care and completethe scheduled questionnaires through REDCap. Participants allocated to the SelfBackintervention group receive access to the SelfBack application in addition to usual care.They use the application to receive personalized exercise recommendations, educationalcontent, and activity goals.The follow‐up period lasts twelve months. Participants complete digital questionnaires atthree predefined assessment moments: three months after study enrolment; six months afterstudy enrolment; twelve months after study enrolment.The primary evaluation moment occurs after three months, corresponding with the mainintervention period. Additional follow‐up assessments at six and twelve months areperformed to evaluate whether observed changes are maintained over time.No physical study visits are required during the follow‐up period. Communication and datacollection occur digitally. If participants experience worsening symptoms or severecomplaints during the study, they are advised to contact their usual healthcare provideraccording to standard care procedures.The study evaluates the impact of the intervention through several questionnairesassessing physical functioning, symptoms, psychological factors, work‐related outcomes,and quality of life.All Patient‐Reported Outcome Measures are completed digitally through REDCap at baselineand during follow‐up assessments at three, six, and twelve months.The primary outcome measure is the Roland Morris Disability Questionnaire (RMDQ). Thisquestionnaire evaluates limitations in daily activities related to low back pain.Participants indicate whether specific functional difficulties are present, with higherscores representing greater functional impairment.Additional questionnaires are used to evaluate different aspects related to low back painand its impact on daily life.Functional disability is additionally assessed using the Oswestry Disability Index (ODI),which measures disability associated with spinal disorders.General health status and well‐being are evaluated using the PROMIS‐29 questionnaire.This questionnaire assesses several domains, including physical functioning, paininterference, fatigue, sleep problems, anxiety, depression, and social participation.Work‐related functioning is evaluated using the Work Ability Index (WAI) and work statusquestionnaires. These assessments examine the participant's ability to perform workactivities and monitor changes in employment situation or work adaptations.Health‐related quality of life is assessed using the EQ‐5D‐5L questionnaire, whichevaluates mobility, self‐care, daily activities, pain or discomfort, and anxiety ordepression.Pain intensity is measured using a numerical pain rating scale ranging from 0 to 10,where 0 represents no pain and 10 represents the worst imaginable pain.Psychological factors related to low back pain are assessed using questionnairesmeasuring kinesiophobia, fear‐avoidance beliefs, and pain self‐efficacy. These includethe Tampa Scale of Kinesiophobia (TSK), the Fear Avoidance Belief Questionnaire (FABQ),and the Pain Self‐Efficacy Questionnaire (PSEQ).Physical activity is assessed through step‐count data, recommended activity goals, andreported exercise volume. Participants in the intervention group provide informationregarding completion of recommended exercises through the SelfBack application.The Saltin‐Grimby Physical Activity Level Scale is used to classify participantsaccording to their general level of physical activity.Healthcare‐related resource use is documented through participant‐reported informationregarding medication use, physiotherapy sessions, and healthcare consultations related tolow back pain.Participants using the SelfBack application are also asked to provide user ratingsregarding their experience with the application. These ratings assess overallsatisfaction, ease of use, and willingness to recommend the application to others using afive‐point scoring system.The SelfBack application records information regarding participant interaction with theintervention. Participants are asked within the application whether recommended exerciseshave been completed and can indicate their performed activities.However, the study does not include direct verification of exercise performance. Reportedadherence therefore reflects participant‐reported completion of activities.The tailoring variables used by the SelfBack system are monitored during the interventionperiod. These variables include information related to pain intensity, function,fear‐avoidance, work ability, sleep, pain self‐efficacy, stress, depressive symptoms, andbarriers to self‐management.The collected information allows the application to adapt recommendations according tothe participant's reported status and progression.The SelfBack application is considered a CE‐marked Class I medical device. Based on thenature of the intervention, no serious adverse events are expected during this study.A possible adverse event related to participation could be temporary worsening of lowback pain due to muscular overload associated with performing exercises. This could occurfollowing repetitive movements or increased physical strain.If participants report worsening symptoms, they will be advised to seek medical advicefrom their usual healthcare provider according to standard clinical practice.Serious adverse events are defined according to applicable medical device studyregulations. No serious adverse events or suspected unexpected serious adverse reactionsare anticipated for this clinical trial.