A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 461
- Locations
- 2
- Primary Endpoint
- Roland Morris Disability Questionnaire
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The analysis of the data will be performed blindly.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Usual care + selfBACK
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
Intervention: selfBACK (Behavioral)
Usual care + selfBACK
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
Intervention: Usual care (Other)
Usual care
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.
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Roland Morris Disability Questionnaire
Time Frame: change from baseline to 3 months
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.
Secondary Outcomes
- Pain intensity(change from baseline to 3 months)
- Pain Self-Efficacy Questionnaire(change from baseline to 3 months)
- The Fear Avoidance Belief Questionnaire(change from baseline to 3 months)
- Saltin-Grimby Physical Activity Level Scale(change from baseline to 3 months)
- Patients Global Perceived Effect(3 months)
- Brief Illness Perception Questionnaire(change from baseline to 3 months)