Low Back Pain
Conditions
Keywords
Digital Decision Support System, App, Self-management
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.
Interventions
BEHAVIORALselfBACK
Participants will use the selfBACK system and app in addition to receiving usual care
OTHERUsual care
Participants will receive usual care
Sponsors
Norwegian University of Science and Technology
National Research Centre for the Working Environment, Denmark
University of Glasgow
Robert Gordon University
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The analysis of the data will be performed blindly.
Intervention model description
The study design is a multi-center randomised controlled trial with 2 parallel arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[completely agree\] |
| 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 \[completely agree\]. |
| 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 \[worst severity\]. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain duration and frequency | change from baseline to 3 months | Pain duration measures patients' self-reported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for LBP. |
| Virtual Care Climate Questionnaire | 4 months | The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting. |
| User ratings | 4 months | Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system |
| Workability | change from baseline to 3 months | Workability is measured by a single-item and rated on an 11-point NRS scale ranging from zero \[completely unable to work\] to 10 \[work ability at its best\]. |
| Physical activity | weekly for 9 months | The patients' weekly recommended step count goal, and the actual achieved step count per. day |
| Exercise volume | weekly for 9 months | The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them |
| Tailoring variables | weekly for 9 months | Participants in the intervention are on a weekly basis asked a set of tailoring questions. These are tracked over the intervention period. The tailoring questions include items on lob back pain (NRS for pain intensity), function, fear-avoidance, workability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management. Note. not all questions are asked on a weekly basis |
| Health-related Quality of Life | change from baseline to 3 months | The EuroQoL 5-dimension (EQ-5D) questionnaire is used to asses quality of life within each of the five dimension (i.e., mobility, self-care, activities, pain/discomfort and anxiety/depression). |
| Activity limitation | change from baseline to 3 months | Activity Limitation evaluates if LBP has limited work and leisure time activities. The questionnaire consists of two single items with response options yes and no. |
| Sleep | change from baseline to 3 months | Sleep is assessed by self-report using four items concerning problems with falling asleep, waking up repeatedly, waking up too early, and feeling sleepy during the day. |
| Perceived Stress Scale | change from baseline to 3 months | a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress |
| Patient Health Questionnaire-8 | change from baseline to 3 months | the questionnaire is an 8-item questionnaire used to evaluate the participants' depressive symptoms. Items are scored on a 4-point Likert scale scoring frequency of experiencing symptoms of depression. |
| Patient Specific Functional Scale | change from baseline to 3 months | Participants rate their function on up to two self-selected activities, are asked to rate if they are unable to do or are having difficulty with the their ability to perform self-selected activities regarded as important by the participants themselves |
Countries
Denmark, Norway
Outcome results
None listed