Randomised Controlled Trial for the selfBACK Project

Study Overview
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Brief Summary
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The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.

Detailed Description
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The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain. The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content; information/education recommended daily number of steps recommended strength and flexibility exercises Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.

Official Title
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A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project

Conditions
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Low Back Pain

Intervention / Treatment
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* Behavioral: selfBACK
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks LBP of any duration Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire Age: ≥18 years Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data) Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser. Exclusion Criteria: Not interested, Unable to speak, read or understand the national language (Danish/ Norwegian), Cognitive impairments or learning disabilities limiting participation, Mental or physical illness or condition limiting participation, Inability to take part in exercise/physical activity, Fibromyalgia (diagnosed by a health care professional), Pregnancy, Previous back surgery Ongoing participation in other research trials for LBP management.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is a multi-center randomised controlled trial with 2 parallel arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual care + selfBACK<br>The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content; information/education recommended daily number of steps recommended strength and flexibility exercises | Behavioral: selfBACK<br>* Participants will use the selfBACK system and app in addition to receiving usual care<br>Other: Usual care<br>* Participants will receive usual care<br>|
| Active Comparator: Usual care<br>Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal. | Other: Usual care<br>* Participants will receive usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire | The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering yes or no to a series of descriptions of functional abilities with higher scores indicating higher level of disability. | change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Self-Efficacy Questionnaire | The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree]. | change from baseline to 3 months | 
| The Fear Avoidance Belief Questionnaire | The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree] | change from baseline to 3 months | 
| Pain intensity | Pain intensity measured as average and worst LBP within the past week. Measured on a 0 - 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable. | change from baseline to 3 months | 
| Brief Illness Perception Questionnaire | The questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity]. | change from baseline to 3 months | 
| Saltin-Grimby Physical Activity Level Scale | Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active | change from baseline to 3 months | 
| Patients Global Perceived Effect | A single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Decision Support System, App, Self-management