Randomised Controlled Trial for the selfBACK Project
- Conditions
- Low Back Pain
- Interventions
- Behavioral: selfBACKOther: Usual care
- Registration Number
- NCT03798288
- Lead Sponsor
- University of Southern Denmark
- 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;
1. information/education
2. recommended daily number of steps
3. recommended strength and flexibility exercises
Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 461
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual care + selfBACK 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; 1. information/education 2. recommended daily number of steps 3. recommended strength and flexibility exercises Usual care 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. Usual care + selfBACK Usual care 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; 1. information/education 2. recommended daily number of steps 3. recommended strength and flexibility exercises
- Primary Outcome Measures
Name Time Method Roland Morris Disability Questionnaire 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 Outcome Measures
Name Time Method Pain intensity change from baseline to 3 months 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.
Pain Self-Efficacy Questionnaire change from baseline to 3 months 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 \[completely agree\].
The Fear Avoidance Belief Questionnaire change from baseline to 3 months 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 \[completely agree\]
Saltin-Grimby Physical Activity Level Scale change from baseline to 3 months Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active
Patients Global Perceived Effect 3 months 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
Brief Illness Perception Questionnaire change from baseline to 3 months 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 \[worst severity\].
Trial Locations
- Locations (2)
Norwegian University of Science and Technology
🇳🇴Trondheim, Norway
Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark
🇩🇰Odense, Denmark